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Regulatory Affairs Scientist



Introductie

Do you have multiple years of experience in regulatory affairs within the pharmaceutical industry? As the Regulatory Affairs Scientist you will make sure new products will be on the market as soon as possible and provide regulatory support for the products that are already on the market.

Het bedrijf / The company

An international pharmaceuticial company involved in the manufacturing of biopharmaceutical products



De functie / The role

Do you have multiple years of experience in regulatory affairs within the pharmaceutical industry? As the Regulatory Affairs Scientist you will make sure new products will be on the market as soon as possible and provide regulatory support for the products that are already on the market.

The Regulatory Affairs Scientist will work together with the Regulatory Liaison to organize the rapid release of new products on the market

  • You are also responsible for the regulatory support of products that are already on the market
  • You also will have input in the development, life cycle management and post-approval.
  • You will help making documents and assist in development of processes related to the regulatory submissions
  • You will support the marketing autorization applications (MAA) in the EMEA region during the registration process, life-cycle management and the submission of MAA
  • You will advice on documents/protocols regarding Clinical Trail Applications (CTA)
  • This is a hands-on position, so no strategy will be involved


Het profiel / Your profile

For this position as a Regulatory Affairs Scientist we are looking for a candidate with a university degree and 3 years of relevant experience

  • Bsc/Msc degree with 3 years of RA experience within the pharmaceutical industry
  • You have great project management, communication and organizational skills
  • You have knowledge of regulatory guidelines and pratice within the EMEA region
  • You are fluent in English and Dutch


Het aanbod / The offer

  • A secondment contract via CheckMark for 6 months, with anticipated extension
  • Part-time position of 32 hours, 24 hours is discussable for candidates with a lot of experience
  • Working at home is possible, but you must be in Leiden 2 days / week


Reactie / Reaction

Neem voor meer informatie contact op met Esther Moerdijk: 0182 590 215
Vacaturenummer: 6331




Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
CheckMark Labrecruitment
Vacaturesteller:
CheckMark Labrecruitment
Standplaats:
Regio Leiden

Geplaatst op FMF: 04 juli 2019

Branche: Farma & Biotech, Healthcare
Functie: QA / regulatory, Clinical research
Opleidingsniveau: HBO / BSc
Werkervaring: 2-5 jaar, 5-10 jaar