Regulatory Affairs Manager - Support a Blockbuster Biological product and receive great training! BE

Reference: TM280921E

Expiry Date: 28-11-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Regulatory Affairs Manager - Support a Blockbuster Biological product and receive great training!

We have a new Regulatory Affairs Manager role 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.

Location: Based in Brussels, Belgium

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!

You will initially be supporting a Blockbuster Biological product, driving the preparation of a global dossier for new indications and supporting regulatory submissions in international markets. You will receive great training and support to become a Senior Manager or Associate Director involved in the design of Global regulatory strategies and drug development plans leading all agency interaction and responses to scientific advice  meetings.

This opportunity will fit a regulatory professional who wants 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.

On offer  is  a strong  and bonus with  full medical and healthcare coverage for you and your family, 50 holiday days a year, flexible working options (even after COVID)  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.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or 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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