CMC Regulatory Manager
My client are global bio-pharmaceutical looking for a CMC Manager to join their site in Belgium. The company are at the forefront in the production of biologicals offering employees an opportunity to grow and develop within the company in local and global roles.
The RA Manager, Cross-Product will manage Company’s regulatory activities related to cross-product changes, worldwide. The job holder will plan and manage regulatory activities in accordance with the defined strategies and priorities. Appropriate preparation, submission and follow-up of the registration files will ensure a successful and timely approval. Management of these activities includes efficient communication with internal stakeholders (Supply, QA, QC..), Local Operating Companies (LOC’s) and regulatory authorities.
- Be responsible for Vaccine Registration activities of one or several projects related to cross-products
- Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility
- Work to the agreed strategy and actively take steps to ensure the deadlines are met.
- Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions.
- Ensure the plans are updated and communicated appropriately
- Communicate with external regulators on specific enquiries
- Maintain close contacts with the LOC’s to ensure shared objectives are achieved
- Exhibit a solid understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
- Good understanding of Global Regulatory requirements and develop specialization in some areas of the RA regulations.
- Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
- Participate in (or lead) the Regulatory Interface Team and gives feedback on their specific areas of expertise
My client require a minimum of 7 years experience in Regulatory CMC candidates must also have a life sciences background and experience in global registrations and submission.
Experience in vaccines or biologics would be advantageous.
Arc7 are acting as a recruiting business in relation to this vacancy. We can only accept applications from EU candidates.