REGULATORY AFFAIRS OFFICER

ElseneIIndustrie pharmaceutique

Description de fonction

As a REGULATORY AFFAIRS OFFICER you will be responsible for the following tasks:

  • 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, you 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.
Profil
  • You have a university degree in a scientific (biochemical / chemical / ...) discipline. 
  • You have at least 2 years of relevant experience in regulatory affairs. 
  • You have international regulatory experiencefor full registration (not local experience).
  • You have excellent knowledge of English and preferably Dutch as well. 
  • You have excellent planning skills and you are proactive and flexible. 
  • You are a collaborative teamplayer. 
  • You have excellent cross-cultural awareness and understanding.
Descriptif de l’organisation et du département

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

For one of our pharma clients in Elsene we are looking for a REGULATORY AFFAIRS OFFICER (M/F). 

Offre

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.

Avez-vous des questions?
Bénédicte Joret Technical Projectsourcing Select Projects +32 3 203 50 88
REGULATORY AFFAIRS OFFICER Informations offres d'emploi
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