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. We offer our employees genuine opportunities for development, 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 then, the company has grown to employ 700 people worldwide, including its division 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 patients' lives is our passion.
The Position: We are looking for a Regulatory Affairs Manager, based in the UK, Germany, Poland, Croatia, or home-based.
· Join a small but growing team of around 8 people working on a wide range of projects and therapy areas across all phases.
· Enjoy a friendly, professional working environment.
· Receive a competitive salary plus a good benefits package.
Requirements:
· Proven experience leading the regulatory aspects of clinical studies on an international basis.
· Experience leading small project teams and line managing regulatory associates.
· Ability to handle multiple projects simultaneously.
· A minimum of a science-based Bachelor's degree; higher qualifications are preferred.
Responsibilities:
· Act as Lead RAM for assigned studies, responsible for regulatory management, including developing Regulatory Management Plans, study-specific FMEAs, and final review of CSR from regulatory perspectives.
· Provide regulatory training to junior regulatory staff.
· Evaluate and summarize data; prepare and submit documentation related to clinical studies (CTA, amendments, end-of-study notifications, progress reports, CSR submissions) to regulatory authorities, liaising with these authorities on behalf of the Sponsor.
· Serve as the primary contact for the Sponsor’s regulatory group, managing all regulatory documentation to support clinical study applications.
Location: You can be office-based or home-based in any country where we have an office.
Why Should You Apply?
· Be involved in a wide range of interesting projects and studies.
· Have your achievements and hard work recognized.
· Work for a growing company with opportunities for career progression.
· Join a reputable company that values its relationships with clients and employees and invests in both.
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