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Regulatory Affairs & Pharmacovigilance Specialist
Fresenius Medical Care. Act as the main contact for regulatory affairs and pharmacovigilance matters for internal teams .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Pharmacovigilance within the pharmaceutical industry, managing product lifecycle activities and ensuring compliance with UK regulations and standards. Proficient in regulatory submissions, safety reporting, and collaboration with cross-functional teams and external partners.
Highest-signal resume keywords
Regulatory Affairs ExperiencePharmacovigilance ManagementRegulatory SubmissionsGxP KnowledgeCompliance Tracking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsPharmacovigilanceProduct Lifecycle ManagementQuality Systems ManagementSafety ReportingRegulatory ComplianceMarketing Authorisation ReviewGDP KnowledgeAnalytical SkillsProblem-Solving
Soft Skills
Effective CommunicationStakeholder ManagementCollaboration SkillsOrganisational SkillsProactive Mindset
Tools & Technologies
MS OfficeCollaboration PlatformsIT Systems
Industry Keywords
Pharmaceutical IndustryRegulatory AffairsPharmacovigilanceGxPComplianceLocal Regulatory FrameworksHealth-Authority QueriesMarket LaunchPost-Market ComplianceTraining Support
About the role
Key responsibilities & impact- Act as the main contact for regulatory affairs and pharmacovigilance matters for internal teams
- Manage regulatory activities across the full product lifecycle, from approval to post-market compliance
- Manage pharmaceutical quality systems
- Support product registrations, submissions, and timely market launches
- Provide regulatory advice on local and global requirements
- Collaborate with cross-functional teams and external partners
- Manage local pharmacovigilance activities, including safety reporting and audit support
- Act as key contact for pharmacovigilance matters with global teams and respond to health-authority queries
- Maintain and update marketing authorisations and related documentation
- Review product labelling, artwork, and promotional materials
- Monitor regulatory changes and communicate updates to stakeholders
- Support the local responsible person with GDP-related activities
- Ensure compliance with internal procedures and regulatory standards
- Support training, process improvements, and compliance tracking activities
Requirements
What you’ll need- Degree in Life Sciences or a related discipline
- 3–4 years of experience within regulatory affairs and pharmacovigilance
- Proven experience in Regulatory Affairs within the pharmaceutical industry
- Preferred hands-on experience with regulatory submissions, compliance, pharmacovigilance, and product lifecycle management
- Desirable experience in GDP and Compliance
- Strong knowledge of relevant UK regulations and standards such as GxP
- Experience reviewing marketing materials for compliance with local regulatory frameworks
- Highly organised, able to manage multiple tasks and deadlines
- Analytical and detail-oriented, with problem-solving skills
- Effective communication, stakeholder management, and collaboration skills
- Confidence working with cross-functional teams and external partners, including regulators and suppliers
- Proactive mindset focused on continuous improvement and compliance excellence
- Comfortable using IT systems and standard business tools, including MS Office and collaboration platforms
- Fluent in English; additional languages are an advantage
- Willingness to travel as required
Benefits
Comp & perks- Individual opportunities for self-determined career planning and professional development
- Corporate culture that supports innovative thinking and collaborative solution-finding
- Benefits of a successful global corporation with the collegial culture of a medium-sized company
- Full-time hybrid work arrangement