Business Specialist jobs

• 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