Specialist, Regulatory Affairs

Specialist, Regulatory Affairs

Baxter International

Braine-l'Alleud, Belgium

Summary

Under minimal supervision, the Regulatory Affairs Specialist is responsible for implementing complex regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products in the Benelux region. Serves as a consultant to managers.

Essential Duties and Responsibilities

  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Prepare, review, and approve labeling and SOP's.
  • Provide regulatory advice to project teams.
  • Provide guidance and coaching for areas of responsibility to lower level team members.
  • Respond to regulatory authorities’ questions with strict deadlines
  • Maintain regulatory files in a format consistent with requirements
  • Develop and initiate complex regulatory project plans
  • Manage regulatory activities relating to specific portfolio of products/projects
  • Maintain and update existing regulatory authorizations
  • Lead or represent Regulatory Affairs in project teams
  • Review promotional material for compliance with local regulations
  • Act as back-up Responsible for Information and Publicity (Belgium)

Qualifications

  • Pharmacist or Medical Doctor, with the capability to become registered as the responsible person for Pharmaceutical Information and Publicity.
  • Fluency in French, Dutch and English is a must
  • 5 years of experience in Regulatory or equivalent experience within a pharmaceutical company CRO, or similar organization
  • Written and Verbal communication skills
  • Good knowledge of regulations
  • Negotiation skills
  • Technical system skills
  • Ability to manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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