Associate Manager Regulatory Affairs

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager, Regulatory Affairs to join our UK regional team, supporting our UK and Ireland markets in a hybrid setting. In this role, you will support marketing authorisations and licence maintenance across therapeutic areas while collaborating with local, regional and global colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.,

• Prepare, compile and lead timely marketing applications and post-approval variations through Medicines and Healthcare products Regulatory Agency (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 alongside pre-submission and scientific advice meetings.
• Support UK labelling, artwork and related meetings alongside UK/Ireland promotional and additional risk minimisation material reviews.
• Represent regulatory across commercial, medical, patient safety, quality and global submissions teams within the European Union (EU) regional team.
• Maintain local regulatory knowledge and UK/Ireland compliance while supporting UK and EU clinical trial applications and inspections.
• Develop best-practice user guides, work instructions and standard operating procedures through departmental initiatives.
• You bring a proactive, collaborative approach to regulatory challenges.
  
  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 and ability to manage parallel submissions against firm deadlines and changing priorities.
• Strategic thinking, commercial awareness, excellent written/verbal communication and ability to foster strong global matrix teamwork.
• UK rare disease therapeutic-area experience preferred.
  
  Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment
process. If you have any questions, please speak with your recruiter.