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Principal Regulatory Executive / CMC Variations / Drug Development / Lead Project Teams / Middlesex

Employer
Turner Regulatory
Location
Middlesex
Salary
40,000 - 60,000
Start date
3 Apr 2019
Closing date
3 May 2019

Job Details

Principal Regulatory Executive – operate within cross-functional Project Teams, manage junior staff!! European and International Regulatory scope. Good CMC working knowledge.

The candidate will be responsible for planning Regulatory Submissions, mentoring and/or supervising the work of junior Regulatory Affairs staff, and may be required to Lead cross-functional Project Teams.

You will possess good al-round Regulatory skills and have working knowledge of: Drug Development Regulatory, Registrations and Post marketing/Life-cycle maintenance (particularly CMC Variations); proven experience in the life-cycle maintenance of Centrally Authorised Products.

You will be adept in Registrations and Post marketing/maintenance, seasoned in the following processes: Development Regulatory; CMC; CTD/Dossiers for MAA's (focus on Modules 2 and 3, but also reviewing all Modules 1 to 5); European Procedures: National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing/Life-cycle maintenance: Type Ia, Ib and II Variations and Renewals; Labelling/Artwork, PIL's and SmPC's.

Regulatory Planning, Strategy, Tactics and Implementation experience.

Ideally, you will have an understanding of legislation in relation to foods and nutritional supplements.

5+ years working knowledge of Pharma and/or nutritional supplement products. Project management experience.

A good salary package is on offer, Circa £50,000-£55,000 basic, plus 15% bonus and benefits. Middlesex location.

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 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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