Global Regulatory CMC Lead, GRL CMC, Associate Director - biologic orphan drugs, UK

Employer
Advanced Regulatory (UK & Europe)
Location
Berkshire, UK
Salary
Competitive
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, CMC, Compliance, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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Global Regulatory CMC Lead, GRL CMC, Associate Director - biologic orphan drugs

The location is Berkshire, UK (M4 Corridor). On offer is an excellent financial opportunity and a level of work flexibility post Covid 19.

This will be a Global role, covering the EU, USA and other key markets.

Our client develops rare disease/orphan drugs, aiming to connect patients living with severe and chronic conditions, to cutting-edge science, and in doing so make a real difference to people with unmet needs. This company is structured to develop new medicines, and innovative approaches to quickly deliver therapeutics to provide meaningful advances to patients.

This is a rare opportunity to join a fast-growing Biopharmaceutical company, where you can make a real difference leading high profile projects. It will be challenging, but nevertheless a career-making opportunity.

Regulatory CMC experience with biologics is required for this role - and in particular monoclonal antibodies (mAbs) is ideal.

In this role you will be responsible for the regulatory CMC Strategy of key products, and be part of the senior team setting the Global Regulatory Strategy for the company. Here you will manage a small team of Regulatory CMC Scientists and lead projects in development (Phase I to Phase III), initial MAA/NDA registrations as well as follow through with post-marketing activities. This role will be a combination of Strategy and hand-on project/product management.

The ideal candidate will have 10 years plus in Regulatory CMC in both Biologics and Phama. Experience with Regulatory Strategy, tactics and implementation, Scientific Advice meetings with the EMA/FDA etc. is necessary. Project leadership skills are vital here, along with solid background of doing the heavy lifting – authoring / writing sections of regulatory CMC dossiers for biologic products (IMPDs, INDs, initial MAA/BLAs, as well as module 3 for major Variations).

Interested in the above?
 

To Apply!

To apply, please send a full CV to CV@AdvTalent.com or call Oli Dimitrov or Theo Moore on +44 (0)207 801 3388 or +44 (0)207 801 3384. We are assigned these roles by our client and will provide you with support throughout the hiring process.

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 Regulatory Affairs team know their 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.

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

+44 (0)207 801 3380

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

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8 Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3380
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