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Senior Regulatory Affairs Manager / Top Biopharma / Major Biologic Product / EU & Global

Employer
Turner Regulatory
Location
London
Salary
Competitive
Start date
24 May 2021
Closing date
23 Jun 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Regulatory Affairs Manager, Biopharma; Major Biologic Product, EU & Global & full Regulatory pipeline exposure - Top Biopharma.

The role is focused on a Major Biologic Drug roll-out.

Regulatory Strategy, Project Management, Clinical/Development Regulatory, Registrations and Life-cycle maintenance across European and International Markets.

Fast-growing and successful Biopharma located in Central/West London!! Some flexible working offered.

Regulatory Strategy and Project Leading - EU & Global in scope. Development; Product launches and roll-out.

Are you a 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 in Central/West London. The role is focused on: Clinical/Development, Registrations and Post marketing/Life-cycle Management. Clinical, non-Clinical & CMC combination.

Reporting to The Head of Regulatory Affairs, you will Project Lead & Advise on European & 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, to ensure that all aspects of the European Strategy are 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 5-10 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 Central/West London location which is also convenient for those who live close to London in Berkshire, Surrey, 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.

Company

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Brief Company Description; 

Turner Regulatory Recruitment is headed by Julian Turner, whose knowledge of Regulatory Affairs Recruitment is significant, and connections with talented candidates in this area unsurpassed.

Julian Turner started his regulatory recruitment career in 2005, since when Julian and his team have created an outstanding database of candidates and other contacts who are always happy to take our calls.

Our candidates willingly engage with us because we have taken the time to get to know them and to understand their plans and their career ambitions. Indeed, it is quite likely we placed them in one of their roles over the past 15 years.

We work closely with our clients’ regulatory line/senior management, HR and talent acquisition/internal tecruitment teams. When they have a Regulatory Affairs vacancy, they rest assured knowing we will put forward on average ten or more exceptional candidates.

We are often called in where other recruiters have failed and are able to fill long-standing vacancies quickly and effectively.

We are proud to work with clients such as Roche, Norgine, BioMarin, Vertex, Shire, ReNeuron, Seqirus/CSL and numerous other organisations, successfully placing candidates in permanent and contract roles within Regulatory Affairs.

If you have a Regulatory Affairs vacancy and would like the opportunity to select from a pool of excellent candidates, please contact Julian and the team at Turner Regulatory Recruitment.

 

 

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Company info
Website
Mini-site
Turner Regulatory
Telephone
0203 695 9477
Location
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
United Kingdom

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