Associate Manager Regulatory Affairs

Regeneron UK Limited; Uxbridge; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

Regeneron UK Limited in Uxbridge is seeking an Associate Manager, Regulatory Affairs to support UK and Ireland markets in a hybrid setting. You will lead timely MHRA submissions, manage post-approval variations, and collaborate with global teams to ensure compliant regulatory pathways.

The role requires knowledge of UK/Ireland regulatory processes, experience with post-Brexit pathways, and the ability to communicate strategies across cross-functional partners. A life sciences degree is required.

Qualifications

• Bachelor’s or advanced degree in life sciences, pharmacy or a related scientific field.
• UK/Ireland regulatory experience, 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.

Responsibilities

• 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.

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.

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.

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.

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.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.