Head of Regulatory Affairs UK, Generics - East Midlands

Recruiter
Turner Regulatory Recruitment ltd
Location
Nottinghamshire
Salary
£65,000-£75,000, bonus, car allowance and benfits
Posted
13 Nov 2017
Closes
15 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Lead, manage and guide the Regulatory Team!!; this is a rare opportunity to lead a team of 5 within an successful and expanding company. Great East Midlands location!!

This fast-growing Generics Company has a large range of products. This is a family-run company with significant potential to become a major player in the UK and European Generics market. If you have 8+ years in UK and European Regulatory activity and are seeking more responsibility, this is the opportunity for you. Team Leadership and UK Regulatory activity are the essential ingredients for this role along with experience in European Procedures. Good CMC knowledge.

This individual will be responsible for the Regulatory Team hence this is a key hire. Broad responsibility remit.

Reporting to the CEO, the successful candidate will provide strategic and operational management of both projects and products with a particular focus on commercial objectives. Ensuring the UK Team operates in line with the regional Regulatory objectives and working practices, the candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have good perception of how Regulatory issues can impact on profitability. Representation of the Regulatory Affairs Team at appropriate meetings, both internal and external. The individual will need to keep an awareness regarding changing Regulatory environment, particularly compliance of UK and European licences with relevant National and European Regulatory requirements.

There are a many existing Products to manage and the candidate will be accountable for Regulatory Strategy and Tactics. The person will have responsibility for a defined Portfolio of Products within the geographical remit. The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs. The candidate will possess full Regulatory Life-cycle experience.

Although Line management responsibility is the key to the role, the candidate will need to have a practical background in UK Regulatory Affairs and a good understanding of Project Leadership and cross-functional teams: CMC; CTD/Dossiers for MAA's (all Modules, particularly Module 3); National Submissions/MRP and DCP; Post Marketing/Life-cycle maintenance: Type Ia, Ib and II Variations, Renewals and Line extensions; Labelling, PIL's and SmPC's. Regulatory Intelligence, Promotional material. A demonstrable working relationship with the MHRA and ideally other Regulatory Agencies and contacts within would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background of at least 8+ years within UK, and ideally other European activity. The candidate will demonstrate superb management skills along with mentoring of staff and the ability to develop and expand a team.

This position is based in the East Midlands; some travel will be required.

A significant salary package is on offer for the right candidate, this will include a competitive basic, car allowance, bonus and other benefits.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on the Telephone Numbers provided or by Email, or by clicking Apply Now.