Senior Regulatory Affairs Specialist, Europe
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Brussels • Belgium
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Job Level
About the role
- Provides administrative support during filling and review of new product registrations and post-approval submissions (variations, CHMP referrals, Agency commitments etc.) in the EU and the UK, Switzerland, and non-EU SEE countries
- Plan and coordinate regulatory submissions to ensure timely delivery
- Draft and organize regional administrative documents and liaise with internal teams for completeness and accuracy
- Work closely with Regulatory Operations and Country RA Managers to establish submission timelines and align on submission strategy and execution
- Oversee translation processes for centralized procedures to meet EMA requirements
- Coordinate new product artwork development and/or artwork updates implementation
- Keep regulatory databases updated and ensure adherence to EU legislation and procedural requirements
- Act as a subject matter expert in workstreams and process improvement initiatives
Requirements
- University degree in life sciences or related field
- Several years of experience in the pharmaceutical industry with knowledge of drug development and approval processes
- Strong organizational and project management abilities with the ability to manage multiple tasks and to prioritize them efficiently
- Excellent written and verbal communication in English
- Familiarity with EU regulatory procedures (CP, DCP, MRP) and Module 1 requirements
- Ability to work in an international environment and coordinate multiple stakeholders
- Detail-oriented with strong document review and QC skills
- Proactive, solution-oriented, and eager to contribute to process improvements
- Willingness to travel up to 5% for job-related activities
Benefits
- Flexible Work Arrangements: Hybrid
- Professional Development Opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsdocument reviewquality controlproject managementdrug developmentapproval processestranslation processesartwork developmentadministrative supportEU legislation
Soft skills
organizational abilitiescommunicationdetail-orientedproactivesolution-orientedability to prioritizeability to manage multiple tasksteam collaborationstakeholder coordinationprocess improvement