Belgique 07.06.2022

CMC Regulatory Affairs Specialist

Tasks

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.

Responsibilities:

  • 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.

Requirements

  • 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.
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