Derks Vacature Regulatory Affairs

Regulatory Affairs Manager

  • Fulltime
  • Vast
  • Baarn
  • Referentienummer: WL/22-053-DD
Offer
  • joining a team of experts in Regulatory Affairs
  • a challenging position with various responsibilities
  • a social and fast-growing and dynamic organisation
  • an international environment
  • permanent position, starting with a temporary contract
  • competitive salary package with attractive secondary benefits
Position

As a Regulatory Affairs Manager you will be representing regulatory affairs in multidisciplinary teams in technology transfer projects and related development projects and provide input into the product strategy. You will also be responsible for compiling (authoring and reviewing) required CMC technical documentation in compliance with EU and US regulations and guidelines. Also, you will be coordinating and managing the pre- and post-approval regulatory activities for registrations in the EU and US. Other responsibilities as a Regulatory Affairs Manager are performing gap analysis on registration dossiers and indicate the regulatory implications of the analysis and identifying, analysing, and interpreting relevant regulations, and guidance documents covering regulatory requirements for pharmaceutical products and drug-device combination products.

Profile
  • Master’s degree in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry or Bachelor’s degree with equivalent experience
  • at least 4 years of registration experience in a regulatory affairs CMC role
  • experience in pre- and post-authorization regulatory activities both inside and outside of Europe
  • experience with tech transfers in the pharmaceutical industry is desired
  • experience in international and interdisciplinary project team participation
  • communication skills in English: good oral, writing and presentation skills (knowledge of the Dutch language is considered an asset)
  • excellent organization skills, accurate, hands-on mentality
  • enthusiastic and flexible personality and a real team player
Organisation

Our client is a high-level pharmaceutical services organisation, specialized in technology transfers and the development and registration of high-quality generic and innovative products. They are operating on a global level. Their company culture characteristics are informal, accessible and open minded. They are highly motivated in their jobs. It is their plan to expand over the coming years and wish to do so by building up their future team. Therefore, they are looking for a Regulatory Affairs Manager.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/22-053-DD to Sandra van Putten or Dennis Uleman: info@derksenderks.nl.

For further information, please call, text or WhatsApp to Dennis Uleman at number +31 (0)6 82 72 71 33

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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Tagged as: Life Sciences

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