Regulatory Compliance Manager

4 weeks ago


Reading Berkshire, United Kingdom Proclinical Staffing Full time

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.
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.
Manage the EMC portal and act as a regulatory signatory.
Manage third-party relationships and oversee the regulatory budget.
Provide technical advisory role to the business and liaise with KPIs and analysis.
Proven experience in a similar role within the pharmaceutical or medical device industry.
Strong knowledge of UK regulatory requirements.
Excellent project management skills.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.



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