Regulatory Affairs Manager - Maintenance
Regulatory Affairs Manager - OTC - CMC
The Regulatory Affairs Manager recruited for this position will be tasked with the following key responsibilities:
- Consistently managing maintenance of OTC human medicinal products, traditional medicinal products, cosmetics, vitamins, health food, and foods across CEEMEA, LA and AAI regions.
- Efficient, effective regulatory maintenance and compliance to a single quality standard in the most cost effective manner.
Candidates should have proven leadership and management experience in leading a team of CMC specialists providing professional and managerial advice.
On a daily basis candidates will be tasked with:
- Providing Chemistry, Manufacturing and Controls (CMC) oversight and leadership for our marketed OTC products across EMEA, LA and AAI regions. This includes supervision and management of timely preparation and submission of licence variations, licence renewals and responses to queries from Regulatory Agencies.
- To enable CMC resourcing and consultancy services to regulatory affairs initiative team ensuring high quality strategy, preparation and successful approval of CMC components of new applications to meet key initiative milestones and timings.
- Assume regulatory accountability for all CMC related aspects of marketed product lifecycle management ensuring compliance of all products with the applicable regulatory requirements
- Have accountability for the quality of all CMC submissions as assessed by health agencies.
- Manage systems for the tracking and control of regulatory changes. Oversee the development and implementation of RA documentation, policies and procedures.
- Participate in the process of review and approval of promotional materials and labelling for products to assure compliance with respective codes of practise and European regulations.
- Management of the Regulatory Affairs Budget
- To integrate all of maintenance teams activities, improve internal process and working practises, improve business wide communication and integration with all functions in particular with Global RA new registration team
- Work very closely with the rest of the project teams, ensure that registered information flows readily to and from the PhV, Non-clinical, Clinical, Labelling, Quality and Supply chains.
- Working strongly with technical leadership regarding seamless compliance provide regulatory leadership for all post-marketing CMC related activities
Applicants should have experience in the following:
- Good knowledge of pharmaceutical & scientific processes related to drug development and quality controls
- Ten or more years of regulatory experience in one or more of the following regions: CEEMEA, Latin America and Asia.
- Recent extensive experience in CMC regulatory affairs
- Experience of management and development of teams
This role has a salary of circa 70k plus an excellent benefits package with one of the largest pharma companies in the world.
To find out more about Real Staffing please visit www.realstaffing.com