Regulatory Affairs Consultancy Manager - Market Authorisations

NonStop Pharma are currently partnered with a small, growing pharmaceutical consultancy to find a Regulatory Affairs Manager to expand the team.

As a result of an exciting strategic vision of growth, this expanding Pharma company are developing a Regulatory Affairs division. This will join forces with their already established QA & GMP consultancy teams to create a highly effective, exciting portfolio of services to offer their range of clients.

Subsequently, the CEO is looking for a strong, organised and driven individual to manage the Regulatory Services.

The client base is heavily Generics focused, with particular emphasis needed on Market Authorisations & Post Marketing Submissions. Although the clients have a heavy EU emphasis, the company has successful clients overseas, so Chinese and Asian market knowledge can also be utilised, although this is by no means essential.

The successful applicant will be independently leading and starting their own division, with already established clients to be networked with. You will therefore be involved in senior manager meetings surrounding strategy & implementation. They may be a small Business Development element, also.

Ultimately, the client requires someone who has several years of EU experience and can provide expert MA and Post-Marketing Regulatory knowledge, particularly in Europe.

This position will suit an ambitious, driven Regulatory Affairs professional, who is excited by the prospect of building excellent client relationships, and building their own consultancy team as a part of rapid company growth.

The successful candidate will benefit from a rare opportunity to build their own team and career very quickly, with no restrictions on their own growth and enjoying an already established and untapped client base.

Benefits:

- Work in relatively new, growing Pharma company; be a senior figure by joining at right time

- Hire, grow and lead your own team of successful Regulatory consultants

- Work closely with senior CEO and company heads; gain great exposure

- Be a part of strategy and systematic company planning

- Implement your own consultancy plan and lead on client projects

- Gain incredible career development opportunities by joining at the right time; be part of company growth

- Work with a range of generics products and clients

- Provide excellent strategic insight and help improve patient welfare by getting products to market

- Be an expert on a variety of post-marketing submissions, including MAAs

- Due to company's global outreach, work in variety of markets, including Asian markets

Position Requirements

- 5 - 10 years of Regulatory Affairs experience

- Extensive experience with a range of generics products

- Extensive experience with post-marketing submissions

- In depth experience and knowledge with MAAs (Market Access Authorisations)

- Strong knowledge of EU Regulatory Affairs

- Investigational products experience beneficial e.g. INDs

- Experience with Chinese and Asian market Regulatory submissions beneficial

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop NonStopis one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo APSColife sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.