Regulatory Affairs Manager

Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of Regulatory Affairs from clinical trials to lifecycle management in medicines and medical devices.
Responsibilities:
- Oversee the submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products.
- Ensure all submissions to regulatory authorities are of high quality and conducted in a professional and timely manner.
- Author and review technical documentation for alignment with applicable regulations and guidance.
- Act as signatory for appropriate medical device technical file sections and expert reports.
- Represent Regulatory Affairs as part of Research & Development (R&D) project teams and lead regulatory strategy discussions.
- Lead and support regulatory due diligence of new products.
- Manage workload of team for assigned projects in line with business priorities.
- Maintain oversight and responsibility for the artwork process and staff.
- Maintain awareness of existing and new legislation/guidance relating to EU, UK and RoW GxP; Medicines; Medical Devices and related ISO activities.
- Support and manage regulatory officers in the performance of their day-to-day activities.
Key Skills and Requirements:
- Degree or equivalent level within life sciences or chemistry.
- Experience in UK and EU pharmaceutical Regulatory Affairs.
- Experience of line management and/or leading a regulatory team.
- Good IT skills including MS Word, Excel and PowerPoint.
- Highly organized, with strong attention to detail.
- Strong problem-solving skills and ability to work independently.
- Strong communication skills, written and verbal.
If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at j.pawl@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.