RA Manager Benelux

For one of our clients in the region of Leuven, we are looking for a senior Regulatory Affairs Manager :

- Do you have an extensive Regulatory Affairs experience?

- Do you have a strategic mindset with excellent interpersonal and leadership skills?

- Are you a Physician or Pharmacist?

Than don't hesitate to apply, you might be the specialist we are looking for!

--> Open for freelancers!

Job Description 

Main purpose

  • Planning and managing all regulatory activities associated with the local affiliates

  • To act as the local responsible person for distribution of medicinal products

  • Making recommendations for changes within the affiliates

--> Project: at least 2days/w, till end 2017 (possibly longer)

  • To manage the preparation of high quality documentation for all regulatory submissions.

  • To liaise with relevant internal departments and external contacts to ensure regulatory requirements and proactively communicate with regulatory authorities in the BENELUX.

  • To resolve complex regulatory issues.

  • Act as primary resource to the BENELUX regional commercial Units

  • To manage submission strategies and plan regulatory activities

  • Write local SOP’s compliance with GDP, responsible for storage and distribution of all products.

  • Support in application for pricing and reimbursements in cooperation with commercial units.

  • Responsible for handling complaints, quality defects and recalls.

  • Responsible for administrative release of products, maintain the distribution license and manage timely requests for import and export.

  • Act as responsible person for GDP.

  • Degree in Pharmaceutical Sciences or Medical Sciences

  • Extensive regulatory experience (senior role)

  • A full strategic understanding of the drug development principles

  • Line management experience

  • Excellent interpersonal and leadership skills

  • Able to work effectively without supervision

  • Fluent in English, knowledge of French and/or Dutch is a plus

  • Some travel (within and across Europe) may be required

Contact Information 

Ellie Depape
Talent Acquisition Associate
t +3215 21 11 04
m ellie.depape@valesta.com

Application form : RA Manager Benelux

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