Regulatory Strategy Senior Manager in Westminster

General Summary: Reporting to the Director Regulatory Affairs, Distributor Markets & Geographic Expansion Lead, the RoW Senior Manager (SM) will lead and support submissions in Distributor Markets for MAAs and license maintenance. The SM will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.

Key Duties and Responsibilities:

• Regulatory

• Acts as main contact for submission partners i.e. GCC (KSA, UAE, Kuwait, Bahrain, Qatar, Oman), Russia, Israel, Serbia, North Macedonia, Jordan and additional countries added by the Global Expansion Team.
• Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date.
• Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner.
• Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, exemption from local labelling, CTA requirements, etc.
• Ensure all work is compliant with regulatory requirements and company policies and procedures.

• As applicable, support and contribute to local cross-functional and leadership teams to achieve corporate and departmental goals and objectives.
• Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction.
• Attend meetings at local or international Vertex Offices.
• Exemplify Vertex's core values in fulfilling these job duties.

Knowledge and Skills:

• Regulatory

• Relevant industry experience in regulatory affairs, across the lifecycle, and understanding of current trends in local and regional requirements.
• Recognized as a knowledgeable resource for regulatory advice by other departments.
• Experience of managing negotiations with Regulatory Authorities.
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners).

• Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
• Good interpersonal skills and ability to deal effectively with a variety of personalities.
• Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements.
• Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans.
• Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
• Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.
• Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity.
• Proactively identify risks and develop potential solutions.
• Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
• Ability to navigate and be successful in a fast-paced environment while delivering high quality results.
• Excellent communication skills, strong oral/written presentation skills.
• Fluent written and spoken English.

Education and Experience:

• Bachelor's degree in life sciences or M.Sc. or Ph.D. degree.
• Typically requires solid experience in relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience.

Flex Designation: Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility.

Company Information: Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.