CMC Regulatory Affairs Specialist
Aixial Group is an international medium-sized CRO (Clinical Research Organization) part of the Alten Group since 2014, providing complex services in clinical trials (phase I-IV) and non-interventional studies.
We are currently hiring a CMC Regulatory Affairs Specialist.
- 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.
- May operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.
- Scientific degree in a relevant subject (minimum PharmD or science related MSc).
- An experience in regulatory CMC or a 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.