Graduate - Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Communication, Teamwork, Initiative, Proactivity, Academic Curiosity, Integrity, Transparency, Accountability, Diversity, Inclusivity, Regulatory Strategy, Regulatory Compliance, Life-Cycle Maintenance, Health Authority Interactions, Operational Excellence

Industry

Pharmaceutical Manufacturing

Description

Job Description This role will be based in our modern state-of-the-art co-working facilities in Moorgate, London. This site, at the heart of London provides fantastic 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 unwavering dedication to delivering innovative solutions is the driving force behind everything we do. We offer an exciting 2-year graduate programme for graduates that are looking to work with us to deliver on our mission to save and improve lives. Our programme will give you the opportunity to collaborate alongside subject matter experts, bring your own ideas and share real responsibility whilst delivering on meaningful projects alongside a passionate, diverse and inclusive workforce. Our Regulatory Affairs teams bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. 24 Month 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. You will spend…? 12 months in International Regulatory International CMC International Regulatory Affairs CMC is a key component of our company’s strategy to build regional Chemistry Manufacturing and Controls regulatory knowledge and effective local relationships with country offices to deliver appropriate regulatory strategies and deliver right first-time regulatory submissions. As part of the EMEA team you will be one of the regional experts for CMC in Europe, 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 alongside our team in health authority interactions and engagements Work alongside our team to deliver on operational excellence projects and best practises for regulatory science And… 12 months in Regulatory Affairs UK The Country Regulatory Affair team in the UK manages a broad portfolio of prescription medicines for the UK, largely across the vaccine, oncology and infectious disease therapeutic areas and this role is accountable for undertaking a variety of regulatory activities across a range of products for the UK market. Duties & responsibilities Developing regulatory strategy and contributing to regulatory filing activities and documentation for new marketing authorisation (MA) applications and product launches. Life-cycle maintenance of all aspects of the MAs registered particulars. Work alongside our team in MHRA interactions and engagements. Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems. Developing and maintaining a knowledge of European and UK regulatory legislation and guidelines. Work alongside our team Contributing to departmental meetings, ad-hoc projects and issues. Eligibility/Education Fields of study include (but are not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification) Requirement: skill. Competencies and behaviours Operates with a high level of integrity, transparency and accountability Comprehends and aligns with our organization’s core values Aligns and fosters a culture of diversity and inclusivity Demonstrates initiative, proactivity and academic curiosity Encourages and boosts their colleagues through teamwork Demonstrates clear and effective communication Demonstrates a desire to learn and improve their performance through feedback Ability to work both independently and collaboratively in a team structure Eligibility Criteria for Undergraduates: We are looking for students based in the UK who complete their undergraduate degree between 2024 and 2026. Important Note: 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 read): Please complete the online application form by answering questions within the application and upload your CV and Cover Letter in a combined document in the ‘resume/CV’ section. Our standard Future Talent recruitment process is: An online application, a virtual conversation and then a final assessment. Next Steps: In the event of your successful progression to the next stage, one of our future talent team will contact you within two - three weeks of the application closing date. Start Date: September 2026 Equal Opportunity Employer: We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. For more Information visit our Future Talent page! #UKFT25 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Project Temps (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adverse Event Report, Adverse Event Report, Audits Compliance, Biological Sciences, Biomedical Sciences, Biostatistics, Communication, Communication Management, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Immunochemistry, Immunology, Infectious Disease, Life Science, Maintenance Management, Management Process, Microbiology, Operational Excellence, Policy Implementation, Records Retention Management, Regulatory Affairs Compliance, Regulatory Applications, Regulatory Communications {+ 3 more} Preferred Skills: Job Posting End Date: 10/7/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R365863

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Responsibilities

The role involves generating regulatory CMC strategies and developing regulatory strategies for marketing authorisation applications. You will collaborate with teams across regions and contribute to operational excellence projects.