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

Location
Brussels, Belgium
Salary
Competitive
Posted
10 Oct 2019
Closes
09 Nov 2019
Ref
TM/310719RA R5
Contact
Theo Moore
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

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To apply, please send a full CV to CV@AdvTalent.com or alternatively, contact Theo Moore on +44 (0)207 801 3384. We are assigned these roles by our client and will provide you with support throughout the hiring process.
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About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

We provide a high level of service because we believe this matters.

Contact us today to see how we can help you, make that next career move on

+44 (0)20 7801 3380 

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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