Title:  Principal EU Regulatory Affairs

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

The Regulatory Affairs Principal serves as a key member of the regulatory affairs team and is expected to perform with minimal supervision. The Regulatory Affairs Principal is responsible for influencing department regulatory processes and procedures, contributing to and implementing strategies for EU regulatory approval and preparing technical documentation for EU submissions. The Regulatory Affairs Principal ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Regulatory Affairs Principal 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.

Essential Duties and Responsibilities:

• Contribute to and implement EU regulatory strategies for medical device and drug device combination products, in alignment with the overall development plan and enterprise goals, whilst maintaining contemporaneous knowledge of latest EU regulatory developments.
• Collaborates with cross-functional stakeholders (Quality Assurance and Research & Development) to ensure regulatory compliance is maintained and regulatory deliverables are achieved.
• Collaborate with external partners to ensure regulatory compliance is maintained and regulatory deliverables are achieved.
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
• Author complex product submissions and ensure all regulatory activities and documents, to be submitted to regulatory agencies and Notified Bodies, have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance.
• Provide post-market support to market-released products as necessary (e.g. change control, post-market surveillance).
• Collaborates with Regulatory Policy & Intelligence in maintaining up-to-date knowledge of EU regulatory policy trends and developments.
• Creation, review and maintenance of EU regulatory Standard Operating Procedures (SOPs), work instructions, or policies
• Other duties as assigned.

Basic Qualifications: 

• Education: Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline or equivalent experience.

• Experience: Bachelor’s with 8-10 years; Master’s degree/PhD with +4 years Regulatory Affairs experience supporting medical devices and/or drug-device combination products.

Preferred Knowledge, Skills and Abilities:

• Advanced knowledge of the European Medical Devices Regulation, (EU) 2017/745, and associated guidance (e.g. MDCG Guidance Documents) and Quality Management System requirements (i.e. ISO 13485).
• Knowledge of medical device ‘horizontal’ international standards (e.g. ISO 14971 and ISO 14155).
• Knowledge of European regulatory requirements for drug-device ‘combination products’ (e.g. EMA/CHMP/QWP/BWP/259165/2019 and EMA/37991/2019).
• Experience in medical device and/or drug-device combination product design and development.
• Experience in Technical Documentation compilation, review, and submission for medical devices and/or drug-device combination products.
• Excellent oral communication and technical writing skills
• Self-motivated with a proactive attitude and the ability to work effectively
• Experience in directly engaging with health authorities (e.g. pre-submission meetings, responses to regulatory information requests etc.).
• Knowledge of EU and US medicinal product (including drug led combination products) regulatory submission requirements (e.g. MAA, NDA, ANDA).
• Knowledge of US FDA regulations on medical device and combination products.
• Knowledge of EU Post Market Surveillance (PMS) requirements.
• Advanced degree. 
• R.A.C certification(s).
• Experience with administration and drug delivery systems preferred (single integral and co-packaged).

Travel Requirements:

• Must be able to travel up to 5 – 15 % of the time (meeting, trainings, projects, industry events), including international travel.

Physical & Mental Requirements:

• Sedentary environment; ability to work 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).

Competencies/Authorities

• Non-US only where required for certain levels

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.