This position is open for candidates with a first experience in Regulatory Affairs who would like to focus more specifically on CMC Regulatory Affairs and Compliance.
Job Description
As CMC RA Consultant, you will be responsible for the coordination of all steps of registration process (RoW), for the compilation and the follow-up of files following local regulatories.
Responsibilities
- Execution of Regulatory CMC submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's…) to regulatory agencies. Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides.
- Depending on experience, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.
- Preparation of CMC information for submission to regulatory agencies.
- Ensure that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff… in order to discuss and define regulatory applications (Quality Module, Responses, Commitments.
- Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities.
Requirements
- University degree, Scientific (chemical, biochemical)
- First experience in RA
- Fluency in English
- A first experience in Vaccines is a strong asset.
- Existing right to work in Europe required
Benefits
- Balanced salary package (including a company car, fuel card, 12 additional holidays, insurances, etc)
- Full-time consultancy position (open for employee and freelance)
Vacancy number: 20157
