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5 months ago
Regulatory Affairs Manager, Manchester, £competitive depending on experience
My client is an established market leader in the Pharmaceutical Manufacturing space. After years of consecutive year on year growth, they are now looking to embark on their next 5 year plan and expand into new markets and grow existing specialisms.
Following an internal move, we have been engaged to recruit an experienced Regulatory Affairs Manager to join the organisation to coordinate client liaison in relation to regulatory activities and to ensure production activities comply with individual marketing regulations.
duties will include;
- Co-ordinate all client liaison with respect to new Marketing Authorisations (MA) or changes to existing 'MAs.
- Ensure that changes to all site documents relating to client requests and information are reviewed and amended via Change Management as appropriate.
- Review and approve client artwork for packaging components for compliance with the MA and known labelling legislation.
- Member of the site Change Management Review committee in relation to changes affecting client documents and systems.
- Liaise with clients in order to obtain Annual Product Quality Reviews and Stability Data and Technical Agreements in support of Qualified Person (QP) release on site.
- Assist and lead on various site Projects.
- Assist in regulatory/client inspections as required.
- To support and co-ordinate the QA documentation team.
- Responsible for document archiving and retrieval.
- To provide day to day regulatory support for all manufacturing operations linked to client products.
- To monitor compliance with Manufacturers Licence and individual MAs of Company and clients.
- The review and approval of master documents for manufacturing, packaging, Process Amendments and other quality documents as appropriate.
- To assist with inspections by external auditors e.g. MHRA.
- To coach and mentor other staff in relation to regulatory requirements.
- To resolve regulatory/quality issues relevant to new product introduction, including outsourced manufacture, preparation of technical agreements, documentation, compliance and compatibility with client and site requirements.
- To liaise directly with client companies and regulatory bodies concerning regulatory/QA issues.
- To coach and mentor QA documentation Team.
- Improve document issue and review throughput.
To be considered for this role, candidates should have a minimum of 3 years experience in a similarly high profile Regulatory Affairs role, ideally in the Pharmaceutical industry.
To apply please forward your details for immediate consideration.
Scantec specialises in the Manufacturing, IT, Technical, Engineering and Scientific Sectors. Scantec provide highly qualified and experienced personnel in a compliant and professional manner on both a permanent and temporary assignment basis.
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