Description
- Manage the OTC Maintenance & Compliance team, ensuring all key milestones are met
- Prepare and manage variations and renewals, coordinate submission of renewals and change control requests
- Coordinate the preparation and conduct the review of responses to questions raised by the regulatory authorities
- Deputise for the Associate Director of the Maintenance & Compliance Team when required
Develop and implement regulatory strategies, enabling the routine maintenance activities for approved marketing authorisations to meet regional and country requirements - Performance management, ensuring high quality regulatory dossiers are submitted and responses to the Health Authority are in accordance to standards and legislation
- Work closely with joint venture OTC RA teams, ensuring registered information flows readily to and from central RA