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Associate Liaison, Regulatory Affairs – Europe
MSDRegulatory Affairs Associate Liaison responsible for administrative support in medical advancements at a global healthcare company. Collaborating with cross-functional teams for regulatory submissions in Europe.
About the role
Key responsibilities & impact- Provides administrative support during filling and review of new product registrations and post-approval submissions
- 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 to meet EMA requirements
- Coordinates 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
What you’ll need- University degree in life sciences or related field
- Up to 5 years of experience in the pharmaceutical industry with knowledge of drug development and approval processes
- Strong organizational and project management abilities
- 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
- Experience with AI-enabled tools (e.g. for document management, data review, process efficiency, or knowledge retrieval)
- Willingness to travel up to 5% for job-related activities
Benefits
Comp & perks- Flexible work arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsdrug developmentapproval processesdocument reviewquality controlproject managementprocess improvementtranslation processesEU legislationEMA requirements
Soft Skills
organizational abilitiescommunication skillsdetail-orientedproactivesolution-orientedability to coordinate stakeholdersteam collaborationtime managementadaptabilityinternational work experience