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About the Role
Regeneron is seeking an Associate Manager, Regulatory Affairs to support UK and Ireland markets in a hybrid setting. This role involves supporting marketing authorisations and licence maintenance across therapeutic areas, collaborating with local, regional, and global colleagues in a fast-growing, science-driven organization.
Responsibilities
- Prepare, compile, and lead timely marketing applications and post-approval variations through MHRA pathways.
- Support submission strategies, negotiate with MHRA partners, and communicate implementation to UK and Ireland teams.
- Author, review, and manage module documents, responses, and UK Paediatric Investigational Plans.
- Support UK labelling, artwork, and related meetings, as well as UK/Ireland promotional and risk minimisation material reviews.
- Represent regulatory affairs across commercial, medical, patient safety, quality, and global submissions teams within the EU regional team.
- Maintain local regulatory knowledge and UK/Ireland compliance.
- Support UK and EU clinical trial applications and inspections.
- Develop best-practice user guides, work instructions, and standard operating procedures.
Requirements
- Bachelor’s or advanced degree in life sciences, pharmacy, or a related scientific field.
- UK/Ireland regulatory experience, approximately up to two years, managing Type II clinical variations and approvals through MHRA pathways.
- Experience handling post-Brexit UK applications and regulatory pathways.
- Knowledge of clinical trial requirements, procedures, and EU medicines development.
- Regulatory database proficiency.
- Ability to manage parallel submissions against firm deadlines and changing priorities.
- Strategic thinking, commercial awareness, excellent written/verbal communication skills.
- Ability to foster strong global matrix teamwork.
- UK rare disease therapeutic-area experience preferred.
Skills
- Regulatory Affairs
- MHRA Pathways
- Post-Brexit UK Applications
- Clinical Trial Requirements
- Regulatory Database Proficiency
- Strategic Thinking
- Commercial Awareness
- Communication Skills
- Teamwork
Location
- Uxbridge (Hybrid)
Work Type
- Hybrid
Experience Level
- Associate Manager
- Up to two years of UK/Ireland regulatory experience
Education Level
- Bachelor’s or advanced degree in life sciences, pharmacy or a related scientific field
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.