דרושים Director Regulatory Affairs ב-West Pharma ב-United States, West Whiteland Township

• This position will join a team of transformation leaders to streamline processes and harmonize systems, while enhancing data governance across multiple platforms. The role collaborates closely with business units to align their objectives with West’s technology strategy, which focuses on enabling a secure and sustainable digital infrastructure. This involves eliminating the proliferation of disconnected technology deliveries and ensuring consistent, structured execution.
• As Director, Digital Business Integration for Corporate Functions (HR, Legal, HSE, Finance, and Corporate Development) , this leader will serve as a strategic partner and liaison; bridging business needs with technology solutions, while driving alignment, consensus, and adoption across global functions.

• Align business and technology strategies to enable faster, more effective deployment of digital solutions primarily for West's Corporate Functions.
• Standardize and harmonize processes and data across functions and regions, creating a single source of truth and significantly reducing operational complexity.
• Provide independent focus on optimization and efficiency , minimizing the impact of functional silos and avoiding day-to-day operational distractions.
• Enhance agility and responsiveness , enabling faster adaptation to organizational changes, market dynamics, and business needs.
• Shape and execute West’s digital strategy , ensuring alignment between enterprise transformation goals and the evolving technology landscape, while driving innovation in support of business priorities.
• Partner with leaders across HR, Legal, HSE, Finance, and Corporate Development to ensure technology investments deliver measurable value and are fully integrated into functional strategies.
• Act as a champion for process discipline, data governance, and risk management ; ensuring compliance with global standards while enabling flexibility for local needs.

• Manage a team of around five resources with expertise in digital finance, procurement, and human resources.

• Bachelor's degree in business administration, accounting, information systems, or related fields, or equivalent experience

• Minimum 10 years of experience in project execution, process design, and/or systems implementation
• Experience with SAP (S/4HANA preferred), specifically with Financial Accounting, Controlling, and Human Capital Management modules.
• Experience in the integration of SAP FICO module with HR Systems.
• Experienced business partner with a strong track record of collaboration with C-level executives

• Strong knowledge of and experience with leading practice budgeting, forecasting, analytics, and accounting principles for the typical business processes of a Life Sciences manufacturing company (Order to Cash, Procure to Pay, Record to Report, Hire to Retire, etc.).
• Ability to manage change effectively, including strong interpersonal communication skills that can be adapted to various levels of the organization.
• Experience with Agile project management framework, including setting goals, creating sprint plans, tracking progress, and holding teams accountable for timely delivery.
• Experience and/or training in Generative Artificial Intelligence and Machine Learning, SAP BW/BI, Microsoft Power BI, and other tools in the Microsoft Fabric Platform or similar tools for process automation.
• Ability to lead cross-functional teams collaboratively, encouraging resilience and maintaining a positive mindset.
• Comfort with ambiguity and the ability to logically structure issues and recommend best practice solutions.
• Mindset focused on continuous learning to maintain knowledge of industry trends, new technologies, and evolving best practices.
• Support the legal team’s IT needs, including compliance-focused solutions, secure document management, and data governance processes that strengthen risk management and audit readiness.
• Drive user adoption of digital tools and platforms by building strong partnerships with business stakeholders, promoting collaboration, and ensuring that solutions are practical, intuitive, and value driven.

• Use of written and oral communication skills
• Read and interpret data, information, and documents
• Observe and interpret situations, analyze and solve problems
• Ability to make independent and sound judgements
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, solve problems, and prioritize activities
• Position operates in a professional office environment. May sit or stand for extended periods of time
• This role routinely uses standard office equipment such as computers, phones, and photocopiers

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s degree or equivalent experience is required
• Master’s degree or PhD in science, math, engineering, or related discipline preferred

• Minimum 5 years of relevant experience
• 2+ years of medical device regulatory experience preferred
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
• Advanced knowledge of ISO 13485
• Advanced knowledge of product life cycle, product development process, design control and change control
• Experience interacting with government agencies
• Excellent oral communication, technical writing, and decision-making skills

• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to verbally communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

• Direct and maintain the ERM program and strategy, ensuring alignment with Committee of Sponsoring Organizations' (COSO) ERM Framework and the latest professional standards, and publish/update ERM policies and procedures.
• Establish and lead an Enterprise Risk Governance Council and promote ERM activities and visibility within the Executive Leadership Team and across departments, operating units, and business functions.
• Provide expert risk consulting and advice to all levels of management and business units to ensure comprehensive, high-quality risk reporting and early identification of risk trends.
• Facilitate and coordinate requests for information from auditors, regulators, and collaborate with Financial, Legal, Compliance, Information Technology, Internal Audit, and Operations teams.
• Lead scheduled enterprise risk reporting and presentations for Executive Management, the Audit Committee, and the Board of Directors.
• Review key risk and performance indicators/metrics to assist in early risk trend identification and manage risk self-assessments with business unit management.
• Build strong internal and external alliances to positively influence risk identification and resolution.
• Provide risk support for major initiatives, including M&A activities, related integrations, vendor management projects, and large system/process improvements.
• Direct enterprise risk communication to stakeholders through targeted correspondence and internal networks and oversee the development and delivery of ongoing ERM training programs.
• Assure quality control of enterprise risk-related databases and risk registers and facilitate development and maintenance of department-level risk registers and dashboards in company databases.

• Master's Degree Business Administration, Finance, Accounting, or related field. preferred
• Bachelor's Degree Business Administration, Finance, Accounting, or related field. required

• Minimum 10 years of experience in enterprise risk management, audit, project management, or related field, including 5-7+ years in ERM process development and operation required

• Strong knowledge of COSO ERM framework and other internal control standards.
• Proficiency in risk quantification methods and systems.
• Ability to maintain ERM training and certifications to leverage current experience and enhance the ERM program.
• Strong interpersonal skills with the ability to build relationships across all levels of the organization, including the Board of Directors.
• Consistently demonstrate high standards, professional ethics, integrity, and trust.
• Positive and resourceful with an inquisitive nature, proactively seeking out information to drive successful ERM initiatives.
• Must be able to operate across different geographic time zones.
• Excellent communication and influence skills, including report writing, presentations, and group facilitation.
• Demonstrated executive presence and ability to work independently in a dynamic environment.

• Provide strategic leadership and oversight to ensure regulatory compliance across the product lifecycle.
• Manage highly complex regulatory projects, including drug-device combination products.
• Drive pre-market and post-market regulatory initiatives for successful product commercialization and compliance.
• Collaborate with internal teams such as Research and Development, Clinical, QA, Operations, Commercial, Legal, and Finance to execute key projects.
• Manage and support regulatory personnel in accordance with West and government requirements.
• Assist with US, EU, and ROW clinical programs and regulatory approvals.
• Enhance cross-functional effectiveness and drive continuous improvement in regulatory and quality operations.
• Maintain an up-to-date understanding of health authority guidelines and regulations to shape future regulatory strategies.

• Bachelor's Degree In science, math, engineering, or related discipline required
• Master's Degree In science, math, engineering, or related discipline preferred
• PhD In science, math, engineering, or related discipline preferred

• Bachelor’s Degree with 10+ years; Master’s Degree/PhD 5-8 years regulatory/pharmaceutical experience required
• Experience directly interacting and presenting to project teams, customers, industry groups required

• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Excellent interpersonal, communication and listening skills.
• Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

In this role, the Director of Elastomers & Primary Containment (EPC) Capital Management will spearhead the capital process for function. This will include prioritization for EPC projects, developing and updating strategic plans, budgets, and supporting the forecasting process. You will play a crucial role in formulating capital plans focused on substantial growth initiatives and asset replacements. Enhancing and refining systems for improved accuracy in capital reporting will be a core responsibility. You will liaise with senior management to deliver comprehensive updates on budgets, and year-to-date capital expenditures, while ensuring that Project Expenditure Requests (PERs) comply with both Finance and Global standards.

Capital Prioritization and Management:

• Ensure Budget and Strategic Plan capital alignments are completed for EPC.
• Develop and support capital plans focused on large-scale programs and projects.
• Lead the development of asset management plans to include site facility plans and asset replacement plans.
• Manage the execution of capital plans by leading site review meetings and operation management meetings
• Review project plans to ensure alignment with Global Engineering and Finance guidelines. Project plans also must be aligned with capital budgets and forecasts.

Project and Capital Database Management:

• Maintain an EPC project database ensuring all prioritizations are met and managed efficiently.
• Regularly update and monitor the execution of capital forecasting to meet annual spending requirements.

PER Review and Forecasting:

• Establish and lead PER reviews for EPC, ensuring KPIs such as ROIC, timeline, and payback periods are embedded and reviewed before management oversight.
• Develop comprehensive site forecasts for future project needs in collaboration with site and global engineering teams.
• Collaborate with Finance to manage CAPEX for EPC.
• Other duties as assigned

• Bachelor’s degree with preference in Engineering

• Minimum 10 years of experience; preference for
• Good understanding of general manufacturing and related project management
• Strong expertise of tools like Excel and MS Project.

• 8-10 years’ experience in managing all aspects of complex technical projects to include analytics and scheduling
• Strong capability to manage through influence and across functions
• Strong leadership and strategic thinking, global mindset; anticipates risks, can successfully navigate ambiguity
• High sense for the business; strong business acumen
• Strong coordination and Project Management skills
• Engages others, builds relationships, and creates networks outside team. Checks in with different people to understand the bigger picture.
• Ability to perform root cause analysis and corrective action solutions. Follows through on actions.
• Is curious, agile, engages in new experiences and looks for different perspectives
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Proven ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment
• Make independent and sound judgments.
• Multitask, work under time constraints, problem solve, and prioritize.
• Excellent communicator with ability to maintain confidentiality and resolve conflicts and ambiguity.
• Use written and verbal communication skills effectively.
• Read and interpret data, information and documents to analyze and solve problems.
• Learn and apply new information and new skills.
• Proven ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment
• Make independent and sound judgments.
• Multitask, work under time constraints, problem solve and prioritize.
• Excellent communicator with ability to maintain confidentiality and resolve conflicts and ambiguity.
• Use written and verbal communication skills effectively.
• Read and interpret data, information and documents to analyze and solve problems.
• Learn and apply new information and new skills.

• In this role, you will serve as a trusted senior HR advisor and partner to the assigned management teams (Global Supply Chain, Global Engineering and West’s Integrated Systems Operating Unit(s)).
• You will be responsible for a wide range of HR activities, including Employee Lifecycle Management, Employee Relations, Training, Culture and Engagement, Performance Management, Compensation, and Benefits, while collaborating with teams such as Compensation, Payroll, and Talent Acquisition as needed.
• The successful candidate will demonstrate strong leadership and communication skills to drive organizational alignment, set priorities, and deliver results. You will also ensure that people strategies (attraction, retention, development, and skills alignment) are aligned with business needs and support effective execution.

• Develop and execute HR solutions for assigned client groups, aligned with West’s mission, vision, and enterprise objectives. Gain a strong understanding of business challenges and human capital needs to actively contribute to strategy development.
• Provide leadership, direction, and expertise on complex matters including performance management, succession planning, employee relations, terminations, culture, recruitment & selection, onboarding, organization design, learning, compensation, employee engagement, and workforce planning:
• Provide guidance and input on restructures, workforce planning, and succession planning.
• Proactively coach, advise, and counsel on performance management issues.
• Monitor employee engagement and help design programs and events that build motivation, retention, and overall talent management.
• Address and resolve complex employee relations concerns, including conducting thorough and objective investigations.
• Serve on committees developing employee programs, processes, and procedures, and support their implementation.
• Partner with Talent Acquisition to attract and retain talent, including approval of offers.
• Leverage HR analytics and technologies to improve efficiency, provide meaningful data for decision-making, and support West’s growth in a dynamic industry.
• Support implementation of compensation programs and annual planning in collaboration with Total Rewards. Advise leaders on compensation-related matters, ensuring alignment with company policies and market competitiveness.
• Collaborate with peers across the US and globally to harmonize HR best practices.
• Participate in and contribute to strategic forums, providing HR data, analytics, and guidance (e.g., annual strategic planning, workforce planning, budgeting processes).
• Maintain awareness of external and internal HR trends and provide strategic solutions that add value to the business.
• Continually assess HR-related business needs and provide proactive, solution-oriented consultation to client groups for both immediate and long-term requirements.
• Serve as a change champion, ensuring effective communication and feedback loops to support smooth transitions.

• Bachelor's Degree in Business Administration, Human Resources or equivalent experience required
• Master's Degree MBA preferred

• Minimum 10 years of relevant HR experience in senior leadership role (strategic and operational) required
• Experience within a global organization preferred

• Strong business acumen and ability to assess HR implications of business priorities
• Proven leadership and collaboration skills to motivate and challenge individuals and teams
• Ability to build, lead, and integrate effective people management programs within a business
• Proficiency in Microsoft Office
• Team player with strong interpersonal and communication skills
• Demonstrated decision-making and problem-solving skills
• High level of professional and ethical standards
• Experience working in international, cross-functional environments
• Expertise in organization development, HR, training, performance management, and talent planning

• Strong written, verbal, and presentation skills, including the ability to make quick, sound decisions
• Excellent organizational skills to plan, prioritize, and achieve goals
• Ability to multi-task, work under time constraints, and problem-solve effectively
• Operates in a professional and sedentary office environment, with routine use of computers and phones
• Must be able to work collaboratively and maintain strong working relationships across the organization

• Human Resources\PHR or SHRM-CP SHRM and or PHR Upon Hire preferred

• Develop strong, cross-functional relationships within West Pharmaceutical’s Integrated Systems Operating Unit to establish the FP&A team as a key strategic partner in decision making.
• Analyze month-end financial results, working closely with the accounting team to ensure accuracy and integrity of financial reporting and resolve any discrepancies.
• Collaborate with the Integrated Systems Unit leader and leadership team to support and guide short-term and long-range planning with comprehensive financial analysis and insights.
• Lead the execution of budget, forecast, and strategic plan models, ensuring precision and alignment throughout monthly, quarterly, and annual processes. Conduct variance analysis to aid in performance evaluation.
• Review and influence strategic investments through comprehensive analysis of capital project business cases and Project Expenditure Request (PER) models, ensuring alignment with business objectives.
• Ensure financial planning aligns with organizational goals by identifying key financial drivers, evaluating risks, and providing actionable insights to support informed decision-making.

• Bachelor's Degree in Finance or Accounting required
• MBA, CPA/CFA strongly preferred

• 10+ years supporting the budgeting, forecasting, and long-term planning for a global, publicly traded business

• Manufacturing industry experience
• Excellent technical and analytical skills in finance, forecasting, financial analysis, and budgeting.
• Understanding of business disciplines to develop, analyze and interpret financial data.
• Executive presence and experience presenting to senior leadership.
• Demonstrated ability to work in a team environment on a global basis.
• Strong influencing and change management skills.
• Present analyses and advocate recommended actions to a variety of audiences with self-confidence.
• Ability to multi-task, prioritize tasks, and drive projects to completion with tight timelines.
• Demonstrated ability to learn quickly when facing problems and ability to apply knowledge to new situations.
• Superior verbal, written and interpersonal communication skills.
• Ability to interact with all levels of the organization, including Executive leadership.
• Strong work ethic and integrity to handle confidential/sensitive information.
• Ability to make recommendations and decisions independently.
• Experience using tools and systems such as SAP HANA, Hyperion, PowerBI, SAP BI, Microsoft Office products etc.
• Ability to lead teams and build effective working relationships both internally and externally.
• Strong presentation, communication, and interpersonal skills.
• Self-starter and results oriented independent worker.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Ability to comply with the company’s safety and quality policy at all times.

• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines