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Senior Regulatory Manager / Top Pharma / Biologic/Pharma Products / Flexible working

Employer
Turner Regulatory
Location
Hertfordshire (GB)
Salary
£65,000 to £75,000
Start date
6 Jul 2019
Closing date
5 Aug 2019

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Regulatory Strategy, Regulatory Clinical & Development, New Drug Applications & Product Life-cycle maintenance across European and some International markets. Top 10 Pharma in East Hertfordshire!!

Regulatory Strategy, Project Managing and Leading across Europe. Are you a Senior Regulatory Project Manager/Manager, adept in European Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for. This Regulatory Manager role is for an established and highly successful Pharma with a portfolio of ‘cutting-edge’  Biologic and Pharma Products; this role will be based in a desirable area of East Hertfordshire. The role is focused on a variety of Regulatory activity, including Strategy across Development, New Product Registrations – Centralised Procedure and Post marketing.

Reporting to The Regulatory Group Lead, you will Project Lead & Advise on European Regulatory Affairs Strategy in addition to ‘hands-on’ activity!! Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre and Post approval: CTA’s and other Clinical/Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and principally Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR’s. Ideally, Scientific Advice meetings and PIP's.

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 Regional 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 Early & 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, Pharma or perhaps a CRO background, in European Regulatory Affairs Strategy and Project Management/Leadership with 10 year's+ solid experience, should be suitable for this position.

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

Desirable East Hertfordshire location. 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, or julian@turnerregulatory.com, or submit an application 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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