Graduate Programme – Regulatory Affairs

Job Description

Job overview:

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.

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. With a team of over 70,000 employees spread across 140+ countries, we offer state-of-the-art laboratories and inspiring offices designed to foster growth and development in our team members.

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 practices 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

• You will be looking to complete BSc in a scientific discipline such as chemistry, biological sciences, engineering, or a related field in 2024 or within the last two years.
• 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

How to Apply:

Please complete the online application form 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.

Provisional final assessment dates will be held from November 2024

Deadline:

Monday 7th October 11:59pm 2024

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 2025

Equal Opportunity Employer:

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

For more Information visit our Future Talent page!

#ukft2024

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):

Job Posting End Date:

10/8/2024

• 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.

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