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Senior Regulatory Manager, Innovative Medicines - Europe / Big Pharma / Hybrid Working

Employer
Turner Regulatory
Location
Hertfordshire/Essex Hybrid, UK
Salary
Competitive
Start date
1 Jun 2024
Closing date
1 Jul 2024

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

Job Details

Senior Regulatory Manager, Innovative Medicines - Europe. Hybrid Working.

It is essential that the candidate possesses good Clinical Trail Application (CTA's) including CTR, experience, and is strong in European Regulatory Affairs (Registrations and Post marketing).

Are you already a Regulatory Manager/or experienced Regulatory Project Manager, ready to take the step-up to Senior Manager? If so, this is the opportunity you have been waiting for. This Senior Regulatory Manager, EU is for a fast-growing Pharma Company just to the North of London; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. The company is focused on both Branded and Generic Products.

You will be required to Project Lead and Manage and mentor Regulatory Staff. You will be responsible for the Pre- and Post-Registration and Post Marketing Team and the implementation of EU and Global Regulatory Strategy to maintain the organisation's existing product licences, and to integrate newly approved products into the portfolio.

The Product Portfolio is in Immunology, Oncology, Gastroenterology and Respiratory; however, specific Therapeutic area experience although desirable is not strictly necessary.

Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities.

Technically, you will have good working knowledge and experience of CTA's and other Clinical Development activity, Registrations and Post marketing activity: CTD/Dossiers for MAA's (ideally, all Modules 1 to 5, particularly 1/2/3); National Submissions/MRP, DCP and Centralised Procedure; Post marketing/Life-cycle management: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Your geographic scope will be Pan-European.

Candidates from a Pharma or Biologics background in European Pre- and Post-Registrations with over 5 years' experience, and good Project Management should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

Hertfordshire/Essex location with Hybrid working arrangements.

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
GB

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