CMC Regulatory Manager - Cheshire - GBP45-GBP55k

Science Solutions - Regulatory Manager - GBP45-GBP55k

Expanding Pharmaceutical Manufacturer looking for an experienced Regulatory specialist with ideally 5-10 years experience in CMC Regulatory Affairs

The main purpose of the role is to compose & submit Regulatory CMC Packages to the MHRA

General responsibilities;

• To co-ordinate client liaison in relation to regulatory activities to ensure that each batch of product manufactured for client companies complies with the individual Marketing Authorisations.
• To manage and support the QA documentation team
• Assist with regulatory and client inspections
• 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 issues.
• Improve document issue and review throughput

Requirements;

• Degree or equivalent in a science based subject.
• At least 5 years experience in the pharmaceutical industry to include regulatory CMC Submissions
• Communication skills.
• Management skills - role holder has responsibility for coaching and mentoring other staff in relation to regulatory changes.

Please apply now to be reviewed immediately