Regulatory Affairs Associate Manager

PuursIIndustrie pharmaceutique

Description de fonction For one of our clients in the pharmaceutical industry, we're looking for a REGULATORY AFFAIRS ASSOCIATE MANAGER.

You are responsible for:
  • High quality CMC documentation and applying CMC global regulatory strategies
  • Preparation of CMC responses to Health Authority questions during the full project lifecycle
  • Identifying required documentation for international submissions and negotiation of the delivery of technical source documents alligned with project timeframes
  • Identifying quality and/or content issues with source documentation that may influence submission quality or timeframes in an early stage of the project lifecycle
  • Keeping your knowledge regarding regulatory guidelines and requirements up to date
  • Participation as a member of the global team: contribution to the strategy and identifying critical issues
  • Support of the general department (e.g. DRAGON support, annual and product renewal writing, ...)
  • You report to the RA Manager.
Profil As a Regulatory Affairs Associate Manager you have:
  • Master's degree (Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • You are fluent in Dutch and English
  • You're living in Belgium
  • You have previous experience in Regulatory Affairs
  • Working knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
  • Experience is working with extended, multinational project teams and coordinating activities simultaneously on multiple projects under pressure of time and workload
  • Effective planning and organizational skills
  • A reasonable approach to risk assessment
  • Good communication and negotiation skills
Descriptif de l’organisation et du départementSelect Projects is part of the Select Group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis.

Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro)chemicals, Construction and Rail. From our offices in Antwerp and Rotterdam, we provide optimal support to our experienced specialists so that they can deliver high quality to our customers at all times.Offre You will receive an attractive salary package with interesting extra-legal benefits. A company car, meal vouchers, group insurance and eco vouchers are among the possibilities.

We ensure that you will be working in a pleasant environment with nice colleagues and opportunities to develop yourself and your career. Together with you, we will map out a training programme to suit your future plans.
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