Regulatory Affairs Senior Manager Roles x 3 - Full lifecycle for NME’s - Brussels

Reference: TM011019

Expiry Date: 01-11-2019

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

Regulatory Affairs Senior Manager Roles x 3 - Full lifecycle for NME’s - Brussels

Location: Based in Brussels, Belgium

We have 3 new Regulatory Affairs Senior Manager roles open for an expanding and highly successful Global Biopharmaceutical company with its EU HQ based in Brussels, working on NBE’s across the full project lifecycle.

Join a company with a great pipeline of both early development and late stage biological products in a role that offers great opportunities for development within its EU and Global Regulatory Affairs department. My client has a great reputation for supporting and developing good Regulatory Affairs talent!

Receive  a great salary and bonus with  full medical and healthcare coverage for you and your family, 50 holiday days a year, flexible working options (including 2 days from home )  and a real career development plan aimed at helping you to develop your strategic expertise and project leadership experience so you are ready to move up to the next level.

We have 3 roles open and available:

  • Role 1: Supporting a Blockbuster Biological product you will be driving the preparation of a global dossier for new indications and supporting regulatory submissions in international markets.
  • Role 2: Design of Global regulatory strategies and drug development plans for NME’s in Phase 2/3 for my clients leading indications and then supporting/leading the MAA’s.
  • Role 3: Supporting the early medicines team working on NME’s in Phases 1 and 2 with the option of following these projects through to EOP2 and then MAA.

Each of these roles are working on Biological NME’s and will give you the chance to be more strategic and gain more achievements around Scientific Advice & Health Authority meetings, submitting MAA’s and leading EU and then Global development plans.

Candidates need to have at  years 4 years regulatory affairs experience ideally across a number of different areas of including  Orphan Drug Designations applications, Paediatric Investigational Plans, strategic roadmaps including timelines, feasibility assessments for nonclinical and clinical development, gap analysis and due diligence for product development and approval process.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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