Regulatory Manager

Proclinical is seeking a Regulatory Manager for a new role within the company. This role is crucial in managing the regulatory aspects of the company's product portfolio, which includes pharmaceuticals, medical devices, FSMP, and food supplements. The successful candidate will be responsible for project work, maintenance, and other regulatory tasks. This role is office-based, requiring a presence for three days per week.

Key Responsibilities:

• Oversee new product development, dossier/product file compilation, and regulatory submission.
• Manage product reclassifications and variation submissions to regulatory authorities.
• Handle site transfer projects and review and sign stability protocols and PQRs.
• Maintain technical agreements and perform audits.
• Manage dossier and product maintenance and life cycle.
• Oversee the management of MAs in the UK, including sunset clause.
• Review and maintain SOPs and assist in tender applications.
• Manage the EMC portal and act as a regulatory signatory.
• Manage third-party relationships and oversee the regulatory budget.
• Perform horizon scanning for relevant legislation and regulations.
• Communicate with health authorities and industry bodies.
• Provide technical advisory role to the business and liaise with KPIs and analysis.

Requirements:

• Proven experience in a similar role within the pharmaceutical or medical device industry.
• Strong knowledge of UK regulatory requirements.
• Excellent project management skills.
• Ability to communicate effectively with health authorities and industry bodies.
• Strong analytical skills and ability to manage budgets.

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.