Senior Specialist Regulatory Affairs jobs at West Pharma in Ireland, Dublin

You will be a key strategic partner to our global proprietary business, leading product costing, accounting, and process and system enhancements within the centralized cost accounting COE, supporting West’s Global manufacturing operations across the globe.

We are seeking an experienced leader for this team who has a strong understanding of cost accounting as well as with business process definition, system implementations, and working cross-functionally with the global leadership team. This role is responsible for managing aspects of manufacturing accounting for multiple plants and setting the strategy around costing for the division. This includes developing and monitoring the accuracy of inventory valuation and standard costs in accordance with GAAP requirements as well as month-end financial closing, reconciliations, and reporting.

• Setting strategic goals and long-term objectives within the cost accounting team
• Developing and maintaining policies and procedures within the cost and inventory accounting function and drive consistency and standardization within the wider cost accounting team
• Drive value in West through collaboration with senior leaders to align departmental strategies with organizational goals, and ensure execution on these strategies
• People:• Own inventory valuation and product costing processes within scope of role
• Lead SAP implementation for the FICO module as it relates to plant accounting, product costing, and associated master data as plants transition manufacturing to S4
• Oversee the plant level month end close tasks including the preparation of journal entries, reserve and variance analyses, and account reconciliations for all manufacturing locations supported by the wider cost accounting team
• Responsible for coordinating all the details to develop the annual standard costs in collaboration with FP&A, Supply Chain Planning and Operations
• Ensure appropriate controls and compliance with US GAAP
• Support and assist in the global initiatives relating to cost accounting for all regions/divisions of West
• Support and assist other functions within the business as required

• Bachelor's Degree required

• Minimum 10 years within Cost Accounting with
• Minimum 10 years of post-qualification experience in a manufacturing industry required
• Minimum 5 years of relevant experience as leading the Finance function of a company required

• Extensive knowledge of SAP
• Understanding of the manufacturing environment and the associated financial processes
• Knowledge of supply chain, receiving, inventory flow, operations process and manufacturing principles
• Strong ability to assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem
• Ability to effectively analyze transactional level detail in an enterprise resource planning system and articulate the key findings to senior management
• Ability to multi-task and drive actions to completion under strict deadlines
• Understanding of GAAP and internal control principles
• High proficiency in Microsoft Excel

• MBA, CPA, or CMA
• Prior SAP implementation experience

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Bachelor’s degree in engineering or related science

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

• Fostering high performance culture, focused on efficiency, accountability, collaboration, and continuous improvement
• Supporting all inflowing requests for customer related documents globally
• Managing orders accurately End to End for standard orders, samples, lab orders for proprietary business and contract manufacturing in the relevant ERP system
• Issuing Quotations, Order acknowledgements, Returns, Credit and Debit notes; DA‘s, notifications
• Verifying orders which come in through the OCR queue or webstore
• Taking care of Export and Import handling as well as pricing related activities,
• Initiating new customers through data creation, triggering Item creation
• Updating customer master data and information records through SAP as well as providing copies of certifications, documents etc. for customers.
• Handling Document Control, CMIR incl. Shipping instructions
• Internal stakeholder relationship management (SCM/Ops/Quality/Shared Services)
• Liaising with plants and wider supply chain to identify best way forward in case the customer requested dates cannot be met
• Cooperation with the customer experience unit supporting internal audit findings and projects for continuous improvement
• Other duties as assigned

• High School Diploma GED or equivalent required
• Minimum 3 years in client services or customer service required

• Knowledge or experience with ERP tools like SAP with Sales and Distribution
• Working knowledge of MS Office or the willingness to learn it quickly
• Highly proficient in written and spoken English and one further language of our business areas
• Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Strong learning capacity
• Ability to work independently in global environment
• Understanding of Incoterms and Export/Commercial Documentation Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Communication, quick decision making, interpreting data, reading or writing, must be able to express or exchange ideas with team members
• Must be able to understand direction and adhere to established procedures

The Regulatory Affairs Sr. Specialist is responsible for post market activities for medical devices, supporting department regulatory processes and procedures, supporting strategies, authoring, reviewing, and supporting global registrations. 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.

• Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations and industry standards.
• Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF and vigilance reports and field safety corrective actions to Notified Bodies, EMA, and other global competent authorities.
• Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in West’s portfolio.
• Support West’s medical device EU importation requirements as Importer in accordance with Article 13 of MDR.
• Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose.
• Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken.
• 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 requirements and West 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 in science, math, engineering, or related discipline required or
• Master's Degree in science, math, engineering, or related discipline preferred or
• PhD in science, math, engineering, or related discipline preferred

• Experience: Bachelors with +5 years or master’s degree/PhD with 3+ years of medical device regulatory experience
• Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485 and US FDA regulations (Title 21CFR820), ISO 14971, and ISO 14155, EU combination product regulations (e.g., EMA/CHMP/QWP/BWP/259165/2019)
• Experience in preparation of dossiers for submission to competent authorities including supporting design and development of medical devices and combination products over the product lifecycle
• Strong decision-making, communication, and technical writing skills
• Ability to work independently and manage multiple priorities and ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement in a changing environment

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

• Established scientific and quality expertise with criteria described above
• Experience in direct engagement with regulatory authorities
• Regulatory compliance competency in Quality Management Systems
• Knowledge of US FDA regulations and submission pathways (e.g., 510(k), DMF, MAF, BLA)
• Familiarity with US drug-device and ROW combination product requirements
• Advanced degree and/or RAC certification

• Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time.
• 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).

To position itself to meet the requirements of continuing rapid business growth and future market development, West Pharmaceutical Services have developed a transformation strategy of standardization, simplification and centralization of global accounting operations. In accordance with that strategy, we are migrating our financial reporting systems onto one main SAP ERP.

Reporting to, and working closely with, the Finance Manager, in this role, you will support the migration of finance activities into GFS Dublin as part of Record to Report.

• Analyze current balance sheet reconciliations and clear any unreconciled items prior to migration
• Work with D&T to resolve any system issues identified
• Preparation and review of monthly financial reports, ensuring they are completed in a timely, accurate and efficient manner and in accordance with US GAAP
• Preparation, analysis and review of journal postings
• Preparation, analysis and review of balance sheet reconciliations at month end
• Calculation, posting and review of monthly accruals and prepayments, ensuring that all items are accurately captured
• Review and reconciliation of inter-company accounts
• Preparation of multi-currency bank reconciliations
• Preparation of variance analysis
• Statutory reporting under Local GAAP requirements
• Processing of transactional taxes e.g. VAT
• Support annual corporation tax compliance
• Control environment:
  • Ensure that company financial records are maintained in compliance with company policies and US GAAP and SEC reporting requirements
  • Accountable for ensuring that company policies and procedures (internal controls) are implemented to provide reasonable assurance that the company assets are protected
  • Support the Sarbanes Oxley activities relative to internal controls documentation and testing and segregation of duties
  • Liaise with internal and external auditors
• Process, technology and service:
  • Support deployment of SAP S/4 HANA and other systems e.g. Blackline to garner greater efficiency within the Record to Report function
  • Support implementation of Artificial Intelligence and /or RPA to drive further efficiency and effectiveness in our delivery of accounting services
• Other duties as assigned

• Bachelors degree or equivalent in Finance or Accounting

• Minimum 5 years Candidate requires private industry experience in multinational manufacturing companies; experience in consolidation role preferred required
• Senior Accountant- minimum3+ years of PQE experience

• Qualified accountanti.e.ACA, ACCA, CIMA or CPArequired

• Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
• Use written and oral communication skills
• 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, tight deadlines, problem solve, and prioritize
• Ability to make work independently and sound decision making
• Observe and interpret situations, analyze and solve problems
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

• Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in West’s portfolio.
• Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities.
• Responsible for complaint monitoring and adverse event reporting globally.
• Author with guidance to create PMS Plans, PMS Reports including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports and other reports required by various health authorities along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF).
• Support the creation and streamline of processes to assure proactive surveillance (database searches, questionnaire) and reactive surveillance (complaints handling, field actions) is conducted accurately and efficiently.
• Collaborate with cross-functional team members in collecting, reviewing and analyzing and reporting on safety and performance data to identify potential adverse safety risks or performance trends.

• Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, MS Teams, Outlook, and others as required.
• Adhere to all applicable regulations, practices, and procedures to maintain compliance.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

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

5+ years (with bachelor’s degree) or 3+ years (with Master’s/PhD degree) of medical device regulatory experience.

• Advanced knowledge of global device adverse event/incident reporting requirements
• Attention to detail with planning, time management and organizational skills
• Minimum US Class II and EU Class IIa device experience
• Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971
• International regulatory competency
• Good oral communication and technical writing skills
• Experience with administration and safety systems preferred
• Self-motivated with a proactive attitude and the ability to work effectively
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Regulatory Affairs Certifications (RAC) preferred

• Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
• 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 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.

This position will be responsible to coordinate, execute and maintain trade related programs for West EU locations. The focus will be on executing and maintaining compliance for West products, procurement and sales activities for EU cross-border transactions. The role is responsible to ensure West transactions are compliant with EU national, regional and local import and export laws and requirements and to ensure efficient and consistent cross border transactions.

• Responsible for ensuring West EU import and export declarations adhere to applicable SOP’s to minimize compliance exposure and to optimize costs
• Executes cross border activities according to the EU trade compliance manuals and procedures
• Works with West sites, 3rd party service providers, and customs broker(s) to resolve issues and questions that arise regarding day-to-day customs entries and export declarations
• Provides trade compliance related codes such as HS, export control codes, Partner Government Agency codes, and other compliance related master data for EU imported and exported products
• Maintain and, as necessary, retrieves required records relating to import and export affairs.
• Prepares, submits and maintains special compliance related documentation to support import/export declarations
• Provides transactional support for duty optimization programs such as Free Trade Agreements
• Conducts post-entry audits---Coordinate any Post Entry Corrections, where necessary, with West-designated Customs Broker.
• Reviews and manages documentation required for import/export declarations, use of Free Trade Agreements, Preferential Duty Programs and Duty Drawback Programs
• Participates in and supports operational projects involving or impacting Trade Compliance at West EU facilities (e.g. systems implementations, new business models, etc.)
• Participates in cost-saving and process improvement initiatives for Trade Compliance activities
• Other duties as assigned

• 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
• Must be able to maintain confidentiality and resolve conflicts
• Ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Analyze and solve problems

• High School Diploma required
• Bachelor's Degree Business or relevant field preferred

• Minimum 3 years related experience required

• Working knowledge of EU import/export regulations and TARIC
• AEO certification/program knowledge
• 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 in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy always
• Able to comply with the company’s quality policy always.
• Strong analytical ability
• Solid communication skills
• Ability to speak English
• Ability to work with and within global cross-functional teams