Regulatory Affairs Manager

Uniting Holding; Remote; GBP 60,000 - 80,000; Full time

Job summary

A growing international CRO company is seeking a Regulatory Affairs Manager to oversee regulatory projects across various therapy areas. The role involves leading clinical study regulations, providing training to junior staff, and liaising with regulatory authorities. Applicants should have experience in regulatory affairs on an international scale and hold at least a Bachelor's degree in a science field. This position offers a competitive salary and opportunities for career advancement in a dynamic environment.

Benefits

Competitive salary

Professional working environment

Qualifications

• Proven experience leading the regulatory aspects of clinical studies internationally.
• Experience in leading small project teams and managing regulatory associates.
• Minimum requirement of a science-based Bachelor's degree; higher qualifications preferred.

Responsibilities

• Act as Lead RAM for assigned studies ensuring regulatory management.
• Provide regulatory training to junior staff.
• Prepare and submit regulatory documentation for clinical studies.
• Act as the primary contact for the Sponsor’s regulatory group.

Skills

Leadership in regulatory affairs

Ability to manage multiple projects

Education

Bachelor's degree in a science field

Job description

Regulatory Affairs Manager

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

The Company

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.

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.

Location

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

Why Should You Apply?

• You want to 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.