Regulatory Affairs CMC - late stage projects, gain initial MAA/NDA experience, home 2 days per week

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
You need to sign in or create an account to save a job.

Regulatory Affairs CMC – late stage projects, gain initial MAA/NDA experience, home 2 days per week

Do you want to work on late stage Phase 3 projects for a set of NCEs with multiple indications? Then this role may be for you.

I am hiring for an international pharmaceutical company which has a successful track record in developing and registering new products. This role is for a Regulatory Affairs CMC professional (Manager / Snr Manager Grade) who wants to gain more experience authoring and re-authoring of CMC sections for initial MAAs as well as NDAs. This is a global role and will help you gain significant EU and US experience.

This role is with a growing company that is financially viable and has recently acquired 2 smaller clinical stage companies, adding several novel small molecules to an already busy pipeline.

This role can be located in the UK (Berkshire, M4 Corridor) or mainland Europe.

What will your duties be?

  • You will be working on a late stage Phase 3 programs for a set of NCEs with multiple indications. Authoring and reviewing global and regional Regulatory CMC submission documents (Module 3 for MAA/NDA).
  • Lead as assigned projects in providing regional strategic and operational Regulatory CMC expertise.
  • Manage CMC aspects of Health Authority questions.
  • Have an input in the Regulatory CMC strategy working closely with the leadership team.

What do you need to bring to the table?

  • 4 -7 years of Regulatory Affairs CMC experience, with proven track record of writing / authoring Module 3 for MAA/NDA, post approval variations.
  • Early stage development experience authoring IMPD/INDs, preparing Scientific Advice will be a plus.
  • Experience in direct communication with the Health Authorities on CMC matters.
  • Positive, can do attitude, good communication skills as well as project management skills.

Package & Bens

My client is offering Manager or Senior Manager grading, for these positions, including a bonus, and incentives plan. The company is willing to consider individuals that want to work from home for 2 days a week post-Covid. You will receive continual training and mentoring, from individuals with 15-20 years each biologicals and regulatory CMC.

 

To Apply!

To apply, please send a full CV to Oli@AdvTalent.com, or alternatively contact 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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert