vacature regulatory-affairs

Regulatory Affairs Manager Benelux (home based possible)

Derks & Derks

International role/possibility to work home-based/leading pharmaceutical company/

Offer
  • Strategic Regulatory Affairs position
  • innovative pharmaceutical company with strong pipeline
  • opportunity to work home-based
  • competitive remuneration package
  • fast growing company that rewards initiative and achievement
Organisation

The company is one of the most respected leaders in healthcare. They are focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. The company markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, the company is committed to work with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Currently the company has a great opportunity available for a Regulatory Affairs Manager Benelux.

Position

In this role you are the source of local regulatory expertise in the registration and post-licensing support of pharmaceutical products and medical devices within the Benelux. You give guidance to local RA Officers. You plan and implement regulatory activities in support of new product approvals, marketed product licences and lifecycle management initiatives, in line with regulatory requirements and local business needs. The Regulatory Affairs Manager ensures compliance of product labelling, promotional and other materials. You maintain a network with the relevant regulatory agencies, trade associations and local consultants to support regulatory strategies and implementation. In this role it is possible to work home-based but due to the responsibilities it will require frequent travelling within the Benelux. You are part of the Management Team.

Profile
  • graduate in Pharmacy or other relevant Life Sciences
  • experience in Regulatory Affairs for pharmaceutical products and medical devices (very desirable)
  • sound knowledge of both pharmaceutical/medical device regulations and guidelines
  • experience in cross functional project teams
  • good interpersonal and negotiation skills
  • excellent communication skills, both written and verbal (in English, Dutch and French)
  • ability to cope with high workload and pressure
Response

Interested? Please send your resume and motivational letter by email, with reference to WL/018-081-DD, to Wouter Schepers : info@derksenderks.nl.

For further information, please call Wouter Schepers at number +31 (0)33 472 80 87.

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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