Regulatory Affairs (Senior) Manager - Design EU Strategies & Take the lead for a Centralised MAA

Reference: TM310719RA

Expiry Date: 16-02-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time


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Job Description

Regulatory Affairs (Senior) Manager - Design EU Strategies & Take the lead for a Centralised MAA

Location: Brussels

My client is a highly rated and extremely successful Biotechnology company with a culture driven by patient value creation. They have developed a dynamic and multi-cultural working environment that nurtures autonomy and creative thinking and provides opportunities for individuals to excel in a collaborative, team-based environment. This entrepreneurial mind-set fosters diverse perspectives and drives their passion for impact within the sector.

We are leading the recruitment campaign to find a motivated Regulatory Affairs professional with experience in EU Regulatory Strategies and Drug Development Plans to lead and/or support Biological indications (mAbs), across a number of therapy areas through to initial MAA / and or line extensions or new indications.

You will have an impact and input into a variety of regulatory activities including:

  • Active participation in Scientific Advice procedures with EMA
  • EU and US Paediatric Investigational Plans
  • Orphan Drug Designations
  • Support of New Clinical trials registration applications & Substantial amendments submissions
  • MAA’s via the CeP
  • Investigational new drugs (IND) and pre-IND applications
  • Biological drug applications (BLA), New drug applications (NDA)

You will also receive a long-term career plan focused on both your technical and managerial skills and goals with different long-term career opportunities available, including moving into a Global Regulatory Leadership role, working in Early Phase Development, Team Leadership and/or People Management or becoming a regulatory submissions or therapy expert.

This position is based in a beautiful part of central Brussels and includes a great and highly competitive salary and benefits package, full and comprehensive re-location package and the opportunity to take a leadership role in the development and registration of biological products in development in first the EU and then the US regions.


To apply!

To learn more and apply for this role, please follow the link on this webpage. You can also contact me, Theo Moore on + 44 (0)207 801 3384 or +44 (0)7918 195 166 for an initial discussion about the role and other projects.

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