Associate Manager Regulatory Affairs

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 48,000 - 65,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in the United Kingdom is seeking an Associate Manager, Regulatory Affairs to join our UK regional team in a hybrid setting. You will support marketing authorisations and licence maintenance across therapeutic areas while collaborating with local, regional and global colleagues.

The role offers the chance to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Uxbridge (Hybrid) will be the work location.

Qualifications

• Bachelor’s or advanced degree in life sciences, pharmacy or related field.
• UK/Ireland regulatory experience (up to 2 years) with MHRA pathways.
• Experience with post-Brexit UK applications and regulatory pathways.
• Knowledge of clinical trial requirements and EU medicines development.
• Proficient regulatory databases; able to manage parallel submissions on deadlines.
• Strong strategic thinking, commercial awareness and communication skills.
• UK rare disease experience preferred.

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 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 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.

Skills

UK/Ireland regulatory experience

Post-Brexit UK applications

Clinical trial requirements knowledge

Regulatory database proficiency

Parallel submissions

Strategic thinking

Excellent written/verbal communication

Global matrix teamwork

Rare disease experience (UK)

Education

Bachelor’s or advanced degree in life sciences/pharmacy

Tools

None

Job description

Build our future together: 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.

When & where

Uxbridge (Hybrid)

Discover your role

• 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.

This role requires

• 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.

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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.

Salary and benefits

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
• 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.