An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.
Responsibilities:
1. Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team
2. Have an excellent understanding of and be able to execute activities related to the following key areas;
* Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
* Reclassification of Medicines
* Re-baseline / Remediation dossiers
* License Transfers (giving away and bringing in) including the due diligence of dossiers
* Maintenance of Marketing Authorisations including renewals
* Deficiency responses to authorities
3. Interfacing with regulatory authorities to facilitate the approval of submissions
4. Work with sites (manufacturing, PV service provider)/appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues
5. Act as the primary contact point for Regulatory Affairs with the business units, customers, and other internal/external teams<...