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Principal Regulatory Officer / EU; Pharma & Generic Products / Project Manage

Employer
Turner Regulatory
Location
Hertfordshire/Flexible, UK
Salary
Competitive
Start date
7 Jun 2024
Closing date
7 Jul 2024

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

Job Details

Principal Regulatory Officer / EU; Pharma & Generic Products / Project Manage

Excellent opportunity for a 'top-end' Senior Regulatory Officer, with a background in European Market activity.

This leading Pharma and Generics Company seeks a Principal Regulatory Officer for their European Team; ideally, you will be seasoned in the following processes: CTD/Dossiers for MAA's (Modules 1, 2 and 3); European Procedures: National Submissions/MRP and particularly DCP with knowledge of Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

Working knowledge of Generic or Pharma Product experience. Good connections within the EMEA and European Authorities are an advantage. 3 rd Party liaison.

It is generally accepted that this company is a superb organisation to learn and develop new Regulatory skills.

Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.

Prepare Regulatory Strategies (including advising of the Regulatory requirements) for new Marketing Authorisation Applications / Post-approval Submissions.

Be actively involved in due diligence activities including evaluation of Regulatory Strategy and launch timelines, evaluation of risks and Regulatory costs.

Candidates from a Pharma or Generics background in EU Regulatory Registrations and Life-cycle management with over 5 years' experience, and good all-round Regulatory skills 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.

An excellent salary package awaits the successful candidate including £55,000-£62,000 basic, 20% bonus and leading benefits. Hertfordshire/North of London Location with flexible/hybrid working.

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 9477/07 447 977 330, or by julian@turnerregulatory.com, or apply 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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