Student Placement - Associate Specialist, Regional Regulatory Operations, E at Merck Sharp & Dohme Corp. /Netherlands

, , United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

27 Dec, 25

Salary

0.0

Posted On

28 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Submission Planning, Cross-Functional Collaboration, Regulatory Systems, Process Improvement, Dossier Requirements, Health Authorities, Regulatory Submission, Clinical Safety, Operational Tasks, Team Support, Technical Requirements, Regulatory Procedures, Database Management, Communication

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. Brief Description of Position You will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organisation, in the Regulatory Affairs Operations International team, which is based in Europe. You will support the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective across the Europe, Middle East, and Africa regions (EU & EEMEA). As a member of cross-functional team and for the assigned products, you will support the team to manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes. This position requires a keen interest of the regulatory landscape, its registration procedures and a willingness to understand the technical requirements for dossiers. Primary Activities include but are not limited to: Support the planning and managing of regulatory operation projects from authorisation through delivery to country regulatory affairs teams and/or Health Authorities. Supporting the regulatory submission plan for the assigned projects/products and maintaining the related project milestones. Participate in cross-functional forums and meetings With manager support, drive the submission assembly and delivery process with the Global and/or Regional Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines. Responsible for accessing and maintaining the regulatory systems and databases to fulfill daily functions. Assist in identifying opportunities to continually improve the efficiency of the submission processes and systems and participate in small-scale process improvement projects. Learn knowledge on the regional regulatory procedures on internal and external guidelines and standards. Qualifications, Skills & Experience Requirements You must be currently studying at a UK university and will be looking to complete a 12-month student internship as part of your undergraduate degree. Technical Requirements are flexible, but an affinity for and capability to learn Regulatory Information Management systems to execute operational tasks will be a significant asset. 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: June 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: Intern/Co-op (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: 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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Responsibilities

You will support the regulatory submission creation and registration tracking for the company's regulatory submission targets across the EU and EEMEA regions. This includes managing operational aspects for submission planning and execution of Original Marketing Applications and post-approval regulatory changes.