Regulatory Affairs Manager

Regulatory Affairs Manager - We offer an opportunity to learn, progress and achieve, in a dynamic growing environment.

We are a growing international full service CRO company with an HQ in Guildford UK and major sites across the globe that offers its employees a genuine opportunity to develop, varied and interesting challenges, and recognition for achievement,

The Company: Ergomed established in 1997 by two physicians in Croatia, provides expertise in drug development.  Since this beginning, the company has grown to employ 700 people worldwide including its division of PrimeVigilance and is listed on the LSE.  Our clients value us for our scientific and medical expertise and we have one of the highest client retention rates in the industry.

·      Our innovative site management and study physician model set us apart from our competitors.

·      Helping to develop drugs that improve patient’s lives is our passion

The Position: We are looking for a Regulatory Affairs Manager, to be based in UK, Germany, Poland, Croatia office or home based.

·      We offer the chance to work in a small but growing  team of around 8 people in a wide range of projects and therapy areas,  and across all phases.

·      We offer a friendly professional working environment

·      We offer a competitive salary plus a good benefits package

Requirements:

·      Proven experience of leading the regulatory aspects of clinical studies on an international basis

·      Some  experience of leading small project teams,  and line management of regulatory associates

·      Ability to cope with the demands of multiple projects

·      A minimum of a science based Bachelors degree with a higher level qualification preferred

Responsibilities:

·      Assume responsibility to act as Lead RAM for a study, as assigned by the Head of RA department, and be responsible for the regulatory management of that trial which includes development of Regulatory Management Plan, study specific FMEA and final review of CSR from regulatory aspects

·      To provide regulatory training to more junior regulatory staff

·      Evaluate / summarize data; prepare and submit documentation related to clinical studies (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.) to the relevant regulatory authorities, and act on the Sponsors behalf in liaising with these authorities

·      Primary point of contact for the Sponsor’s regulatory group. Responsible for requesting / receiving all Sponsor’s regulatory documentation to support the Clinical study application

The Location You can be office or home based in any country we have an office.

Why Should You Apply?

·      You want be involved in a wide range of interesting projects and studies

·      You want your achievements and hard work to be recognized

·      You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.

·      You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.