Regulatory Specialist Pharma

3 weeks ago


Nottingham, United Kingdom Gi Group Full time

Pharma Regulatory Manager
Location: Nottingham - Full Time Monday to Friday
Competitive salary, 25 days holiday and excellent benefits
Our client is part of a world leading contract manufacturer in the Pharmaceuticals and cosmetic fields and manufacture iconic brands from the client brief through to the completed product and sold around the world right from their MHRA and FDA approved factoryin Nottingham. Due to ongoing growth they are seeking a Pharma Regulatory Manager to join their Quality team working in a busy, commercial Pharmaceutical environment.
The Regulatory Manager is an integral part of the Pharma production unit, responsible for the maintenance of the Regulatory Compliance of the Pharma business unit. The role works collaboratively with the Pharma QA Manager, Head of Quality, business unit teams,other site teams, customers, authorities and inspection bodies.
Responsible for driving continuous quality improvements and developing the business unit to be as self-sufficient as possible.
Responsibilities include:

- Maintaining certification including MIA, controlled drug and pre-curser licenses
- Planning and facilitating regulatory inspections to ensure compliance.
- Liaising with and answering enquiries from regulators e.g., the MHRA and FDA
- Improving internal processes to reduce risk
- Coordinating with clients and team members to review, manage and maintain product compliance files and dossiers.
- Managing the requests for notarized and legalized documentation
- Answering client regulatory enquiries.
- Maintaining the regulatory database
- Providing regulatory advice and guidance
- Participating and contributing in preparation of departmental documentation
- Acting as regulatory contact for deviations, Change controls and relevant meetings.
- Regulatory watch over the Orange guide, ICH and Eudralex
- Coordinating the review of the Pharmacopeia updates.
- Assisting the Head of Quality and Quality Manager in any other required actions to support the smooth running of the Quality Department.
Knowledge, Skills and Experience
- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Impressive, demonstrable skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strategic thinker with the ability to influence at a senior level.
- Highly customer focused.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a 'can do' attitude.

**Benefits**:
We have a comprehensive benefits package, dependant on the role you are performing.
- 25 Days Holiday plus Bank Holidays
- On-site parking with site security
- Opportunity to be part of an international company
- Onsite subsidised Café
- Cycle to Work Scheme
- Professional Subscriptions paid
- Defined contribution Pension scheme
- Life Assurance
- Employee Assistance Programme
- Rewards for long serving employees (holidays and vouchers)
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated recruitment team and partners with many different Pharmaceutical and Biotechnology and manufacturing clients throughout the globe and the United Kingdom



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