Regulatory Affairs Manager

A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager.

Reference: DBN -SS-4

Duties & Responsibilities

Job Purpose:
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.

Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulat...