Our client is a highly successful pharmaceutical company in Leicestershire, due to continued success and internal promotion they are now looking to recruit a permanent Regulatory Manager
The Regulatory Manager will manage the regulatory department who ensures that the company meets all regulatory and QA guidance / legislation.
Duties and Responsibilities include:
Prepare dossiers for regulatory submission for licensed products through MHRA, Manage Pharmacovigilance in accordance with GMP and License requirements Ensure regulatory compliance of all products and report any deviation to line manager, Registration of products with the Vegan Society and maintenance of an approved product schedule, Manage the Soil Association registration process and assist with annual audit, Ensure all licences are maintained and updated as appropriate, Attend HFMA events and keep up to date with EU/UK legislation and MHRA guidelines, contact with local authority regarding Packaging Waste obligations, Contribute as required to other accreditations systems that the company may hold, Manage the Trading Standard Visit / liaise with trading standards to close out any non-conformances observed, Management of Gov.Gateway/DEFRA account, Preparation of documentation for importation of goods, Manage the Kosher / Halal registration process and assist with annual audits, Manage the FDA registration process, Manage Stability Protocols and product testing, Maintain effective and efficient documentation to ensure easy access for all, Review potential new supplier documentation and ensure that all approvals are carried out in line with the relevant SOP, Review suppliers' material specifications against the approved specification, Liaise with suppliers regarding specification issues, and compliance with legislative requirements such as contamination levels, Manage product packaging approval procedure, in conjunction with Marketing for new products, from artwork through to approval for QC release of finished components, Liaise with relevant department regarding labelling and compliance with product specification, Liaise with Marketing to ensure that all artwork is compliant with brand, Ensure that all product labelling is compliant with UK and EU food and pharma regulatory legislation/guidance on Best Practice, Prepare product documentation (specifications / certifications etc) requested by customers, Liaise with customers regarding product queries, as appropriate, Have an understanding of QMS system and be able to cover, if required, for the QA manager in their absence, Ensure all training is documented in a timely manner and up to date with current regulations
The successful Regulatory Manager will have the following Essential Skills / Qualifications:
Experience in QMS management within a pharmaceutical or food manufacturing environment.
Regulatory experience within a pharmaceutical or food manufacturing environment.
Accuracy and Diligence
Educated to degree level.
Experience in carrying out internal and external audits to meet GMP standards
Desirable Qualification would be a degree in a science-based subject.
Benefits for the Regulatory Manager role include:
£ Competitive and negotiable
35 hour week 9-5 Mon - Fri
28 days holiday
This vacancy is based in the United Kingdom. Barker Ross Staffing Solutions only operates in the UK and can only process applications from candidates who are currently a resident and eligible to work in the UK.
Whilst we endeavour to contact you following your response due to the high volume of applications this cannot always be possible. If you have not had notification within 7 days unfortunately your application has not been successful.
This vacancy is being advertised on behalf of Barker Ross Group who is acting as a recruitment agency.
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