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Regulatory Affairs Consultant

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Sophie Steels
Recruiter



Sophie Steels
Recruiter


Job description

As a Regulatory Affairs Consultant, you will be part of a team that will guide our client  by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. 

  • Support regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
  • Liaise with regulatory colleagues to communicate and resolve potential issues.
  • Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.
  • Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.


Profile

  • Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
  • Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA)  and quality.
  • Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation
  • Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)
  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
  • Dynamic, flexible, enthusiastic and eager to learn
  • Ability to work under minimal supervision and in a team
  • Fluent in written and spoken English 
  • CMC experience is a real asset


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