For one of our clients located in Ixelles, we are looking for a "CMC Regulatory Affairs".
International Regulatory experience for full registration Vaccines dossiers (not local experience). - OPERATIONAL ROLE - Coordination of all steps of registration process (not strategic) - Area concerned is the rest of the world (not US - not Europe - not Japan) - Compilation of files following local regulatories + follow-up + maintenance for Vaccines - Only contact he/she will have is internally (with the affiliates) - RA Support - works independently
- Execution of European Regulatory CMC strategies, 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 EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans. Ensures 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.
- Life Cycle Teams and compliance of commercial products.
- May operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams
Do the above responsibilities fit you like a glove?
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- Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)
- An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (3-5 years prior international regulatory with experience in CMC or in Quality Assurance). Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects.
- Broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.
- Leadership skills, influencing and persuading skills
- Excellent cross-cultural awareness and understanding
- Fluency in the English Language is essential
- Excellent communication, interpersonal and relationship building skills
- A balanced salary package based on your capabilities and experience, including meal vouchers
- Part-time flexible, but not changing every week
- Start : as soon as possible
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 16845