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Regulatory Affairs & Pharmacovigilance Associate
Novo NordiskRegulatory Affairs & Pharmacovigilance Associate ensuring regulatory compliance and driving pharmacovigilance activities. Involves monitoring regulatory environment and providing expert insights to stakeholders.
About the role
Key responsibilities & impact- Ensuring adherence to relevant legislation and internal SOPs
- Overseeing the assessment and submission of registration files
- Contributing to local regulatory proposals
- Maintaining close interactions with Health Authorities
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Pharmacy or a related field
- Proven experience in regulatory affairs and pharmacovigilance
- Strong understanding of regulatory requirements
- Hands-on experience with regulatory submissions and labelling variations
- Excellent communication and interpersonal skills
Benefits
Comp & perks- Health Authority interactions
- Developing, reviewing and updating labelling and promotional content
- Internal PV training
- Managing safety reporting
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 RequirementsRegulatory SubmissionsLabeling VariationsAssessment of Registration Files
Soft Skills
Excellent CommunicationInterpersonal Skills