Senior Regulatory Affairs Manager / Global / Development, Registrations & Post Marketing - Biopharma

Location
Hertfordshire (GB) Buckinghamshire
Salary
Circa £70,000-£75,000 basic, good bonus and leading benefits
Posted
12 Jan 2021
Closes
11 Feb 2021
Ref
10191-1
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Senior Regulatory Affairs Manager, Global – fast-growing Biopharma. Strategy, Clinical/Development Regulatory, Registrations and Life-cycle maintenance across Global Markets – European, USA and International.

Fast-growing and successful Biopharma located North West of London!! Flexible working offered.

Regulatory Strategy and Project Leading - Global scope. Product launches.

Are you a Top-end Regulatory Manager or Project Manager adept in Strategy and Global Development, Registrations and Life-cycle Management activity? If so, this is the opportunity you have been waiting for.

This Senior Regulatory Affairs Manager role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ products; this role will be based in a desirable area just North West of London. The role is focused on: Clinical/Development, Registrations and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination.

Reporting to The Associate Director, Regulatory Affairs, you will Project Lead & Advise on Global Regulatory Affairs Strategy and ‘hands-on’ activity. Product ownership of a recently approved major new drug.

Technically, you will have good working knowledge and experience of CTA’s and other Development Regulatory, New Registrations; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR’s.

Ideally, you will have participated in Scientific Advice meetings with Regulatory Authorities and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the European Strategy is observed and implemented.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Late Phase, through to successful New Registrations and Post marketing.

You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Biopharma or Pharma background, in Global, European & International Regulatory Affairs and Project Management/Leadership with 5-8 year's solid experience should be suitable for this position.

Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate.

Desirable North West of London location which is also convenient for those who live close to London in Berkshire, Hertfordshire, and Buckinghamshire. Some Travel may be required in this role.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330, julian@turnerregulatory.com or by clicking Apply Now.

Apply for Senior Regulatory Affairs Manager / Global / Development, Registrations & Post Marketing - Biopharma

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.