Regulatory Affairs Officer

Park Street People; Reading; On-site; GBP 30,000 - 45,000; Full time

Job summary

A consulting firm in regulatory affairs is seeking a Regulatory Affairs Officer to guide clients in navigating the regulatory landscape for medical products. This role involves preparing submissions for the UK, EU, and US markets, supporting clinical trials, and maintaining client communication. An appropriate degree in Life Sciences or a related field is required, along with an understanding of regulatory requirements and excellent communication skills.

Qualifications

• Degree in Life Sciences, Pharmaceutical Sciences, or Regulatory Affairs.
• Understanding of clinical trials and PMCF requirements.
• Experience liaising with regulatory authorities and clients.

Responsibilities

• Prepare and submit regulatory documents for UK, EU, and US markets.
• Support clinical trial processes and create compliance solutions.
• Research evolving regulatory frameworks.

Skills

Regulatory submissions

Client communication

Problem-solving

Attention to detail

Strong IT skills

Education

Degree in Life Sciences or related field

Job description

Are you passionate about regulatory affairs and eager to help life-changing medical products reach the market? Our client is looking for a Regulatory Affairs Officer to support their team in guiding pharmaceutical, medical device, cosmetics and life sciences companies through complex regulatory landscapes.

Whilst part of a team, you will work independently. Aside from regulatory submissions, you will engage with clients providing regular updates and advice on projects. This is a great opportunity to further develop your regulatory knowledge and consulting skills.

Key Responsibilities

• Assist in preparing and submitting regulatory documents for UK, EU and US markets mainly on medical devices
• Support clinical trial processes, registries and Post-Market Clinical Follow-up studies
• Research evolving regulatory frameworks to keep strategies cutting-edge
• Provide updates, presentations and regular communication with clients across multiple time lines
• Work alongside senior consultants to develop tailored compliance solutions

Requirements

• A degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs or a related field
• An understanding of clinical trials, registries, and PMCF requirements
• Experience liaising with regulatory authorities and clients and presenting detailed reports to them
• Familiarity with global regulatory bodies and frameworks
• Strong IT skills and attention to detail
• Excellent communication and problem-solving abilities

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Agency in relation to this role