REGULATORY AFFAIRS OFFICER

ElseneIFarmaceutische industrie

Functieomschrijving

For one of our pharma clients in the region of Brussels we are looking for a REGULATORY AFFAIRS OFFICER.

As REGULATORY AFFAIRS OFFICER your responsibilities are:

  • 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.
Profiel As REGULATORY AFFAIRS :
  • You have a scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)
  • You have 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)
  • You possess the ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects
  • You have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals. 
  • You have demonstrated leadership skills, influencing and persuading skills
  • You are fluent in English
Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through project sourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Heb je nog vragen?
Marlies Collart Human capital developer Select Projects +32 3 203 50 80
REGULATORY AFFAIRS OFFICER Vacature informatie
74607
Biowetenschappen
Project sourcing
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