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Regulatory Affairs Manager, EU / Innovative Medicines / Big Pharma

Employer
Turner Regulatory
Location
Essex/Hertfordshire/Hybrid, UK
Salary
Competitive
Start date
1 Apr 2023
Closing date
1 May 2023

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

Job Details

Regulatory Affairs Manager - EU - Innovative Medicines

Are you already a Regulatory Project Manager/or experienced Senior Regulatory Associate, ready to take the step-up to Project Manager? If so, this is the opportunity you have been waiting for!!

This Regulatory Affairs Manager - EU - Innovative Medicines is for a well-established Pharma Company in the Essex/Hertfordshire/Northeast London area; this organisation has a highly successful established product portfolio and has expanded into new Therapeutic areas and Drug Development.

You will be required to Project Lead and Manage, but there is no formal Line Management of Staff. You will be responsible for the Drug Development of Products - CTA's and ideally Scientific Advice meetings, PIP's, and Orphan Drug designations (ODD's). New Registrations via National/MRP, DCP or Centralised Procedure and Life-cycle management. You will be responsible for the implementation of EU Regulatory Strategy to maintain the organisation's existing product licences, and to integrate newly approved products into the portfolio. Management of overseas Affiliates and other Partners.

Liaison with appropriate Regulatory Authorities.

Technically, you will have good working knowledge and experience of Development, Registrations and Post marketing activity; CTA's and other Development activity, CTD/Dossiers for MAA's (ideally, knowledge of all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

Your geographic scope will be Pan-European.

In addition. you will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

Candidates from a Pharma or Biologics background in European Regulatory with full Regulatory pipeline exposure and over 5 years' experience and possessing Project Management skills should be suitable for this position. This position would not be suitable for those with purely a Generics background.

A salary of £50,000-£55,000 basic, 10% bonus and good benefits is offered to the right candidate. It is possible that this role can be upgraded to Senior Manager Level subject to the experience of the candidate.

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 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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