Graduate - Regulatory Affairs

Merck Gruppe - MSD Sharp & Dohme; City Of London; On-site; GBP 28,000 - 35,000; Full time

Job summary

A leading biopharmaceutical company in London offers a 2-year graduate scheme in Regulatory Affairs. This role includes rotations in International Regulatory CMC and Regulatory Affairs UK, focusing on developing regulatory strategies, engaging with health authorities, and ensuring compliance. Ideal for undergraduates completing their degrees between 2024 and 2026, fostering an inclusive workplace.

Qualifications

• Looking for students based in the UK completing their undergraduate degree between 2024 and 2026.
• Must possess a right to work in the UK for the program's duration.

Responsibilities

• Generate regulatory CMC strategies and apply regulatory policy.
• Develop regulatory strategy and contribute to filing activities.
• Engage with health authority interactions.

Skills

Integrity

Transparency

Proactivity

Team collaboration

Communication

Independent working

Education

Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry

Job description

Overview

This role will be based in our modern state-of-the-art co-working facilities in Moorgate, London. The Moorgate site provides amenities, support services and collaborative workspaces with convenient transport links.

We are a global biopharmaceutical leader committed to enhancing the lives of individuals through a diverse portfolio of prescription medicines, oncology treatments, life-saving vaccines, and animal health products. Our programme offers a 2-year graduate scheme to work with us on mission-critical projects alongside subject matter experts, with real responsibility and an inclusive workforce.

Our Regulatory Affairs teams facilitate communications and regulatory procedures to ensure swift, compliant activity across agencies worldwide. We are an international network at the forefront of healthcare breakthroughs to deliver reliable and compliant medical products and solutions.

2-year Graduate scheme encompassing two 12-month rotations in International Regulatory CMC (Chemistry, Manufacturing & Control) and Regulatory Affairs UK, both based at our Moorgate, London office.

Programme structure

12 months in International Regulatory CMC

International Regulatory Affairs CMC is a core element of our strategy to build regional CMC regulatory knowledge and local relationships with country offices to deliver regulatory strategies and first-time-right submissions. As part of the EMEA team, you will be one of the regional CMC experts for Europe, the Middle East and Africa.

Duties & responsibilities

• Generate regulatory CMC strategies and learn and apply regulatory policy.
• Assess changes to dossiers in the EMEA region and review submission packages.
• Liaise with colleagues across the region and globally.
• Work with the team on health authority interactions and engagements.
• Contribute to operational excellence projects and best practices for regulatory science.

12 months in Regulatory Affairs UK

The UK Country Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK, across vaccines, oncology and infectious disease, and this role undertakes a variety of regulatory activities for the UK market.

Duties & responsibilities

• Develop regulatory strategy and contribute to regulatory filing activities and documentation for new marketing authorisation applications and product launches.
• Life-cycle maintenance of all aspects of registered particulars.
• Engage with MHRA interactions and engagements.
• Generate and maintain prescribing information, patient information leaflets and packaging components, including artwork management, ensuring regulatory compliance with legislation and company approval systems.
• Develop and maintain knowledge of European and UK regulatory legislation and guidelines.
• Participate in departmental meetings, ad-hoc projects and issue resolution as part of the team.

Eligibility/Education

• Fields of study include (but not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification).

Skills, competencies and behaviours

• Operates with integrity, transparency and accountability.
• Aligns with the organisation’s core values and fosters diversity and inclusivity.
• Shows initiative, proactivity and academic curiosity.
• Works well in teams and communicates clearly.
• Willingness to learn and improve through feedback.
• Ability to work independently and collaboratively.

Eligibility for Undergraduates

We are looking for students based in the UK who complete their undergraduate degree between 2024 and 2026.

Important Notes

• We do not provide sponsorship for UK work visas during or after the graduate program.
• To be eligible for the 2-year program, you must have the right to work in the UK for its entire duration.

How to Apply

Please complete the online application form, answer the application questions, and upload your CV and Cover Letter in a combined document in the resume/CV section. Our standard Future Talent recruitment process is online application → virtual assessment → final assessment.

Next Steps

If progressing to the next stage, a member of our Future Talent team will contact you within two to three weeks after the application closing date.

Start Date

September 2026

Equal Opportunity Employer

We are committed to a diverse and inclusive workplace. We encourage respectful challenge and collaboration, and are an equal opportunity employer.

Additional Information

For more information, visit our Future Talent page.

Requisition ID: R365863