Day to day responsibilities:
- Providing regulatory knowledge on ingredient and product changes/maintenance issues.
- Act as companies QPPV for external markets.
- Co-ordination of regulatory documentation to support product changes and registration in both the UK and international markets.
- Produce regulatory dossiers for registration in international markets.
- Provide appropriate summaries and options resulting from changes to regulations.
- Provide training to staff in regard to regulatory changes and for mandatory revisions.
- Lead the organisations Pharmacovigilance requirements
Are you right for the role:
- BSc in Pharmacy/Chemistry or related discipline essential.
- 6+ years’ experience in Regulatory Affairs.
- Experience of working with regulatory bodies such as VMD or MHRA.
- Knowledge and understanding of the role and responsibility of a Qualified Person for Pharmacovigilance.
- Experience of product registration in international markets.
- Previous experience working to GMP compliance.
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