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Regulatory Specialist Pharma

Employer
GI Group
Location
Nottingham, Nottinghamshire, England
Salary
Negotiable
Start date
7 Nov 2022
Closing date
5 Dec 2022

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Job Details

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 factory in 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.
* Preparing and coordinating licence applications and variations to the MHRA
* 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)

If you are interested and feel you have the right skills or wish for a confidential discussion then please apply to this role.

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

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.

Company

Gi Group is one of the world’s leading staffing solutions companies, providing specialist services for the development of the labour market. Gi Group’s specialist Pharmaceutical Division supply high quality temporary and permanent staff to Pharmaceutical and Biotechnology organisations nationwide.

Gi Group’s Pharma Team can support clients onsite or remotely from Gi Group central offices and are specialists in their field with experience within the Pharmaceutical, Biotech and CRO industry.

The Group is active in the fields of temporarypermanent and professional staffing, search and selection, executive search, outsourcing, training, outplacement and HR consultancy.

Thanks to our direct presence and strategic partnerships, we operate in more than 40 countries across Europe, APAC, the Americas and Africa.

Able to serve all kinds of clients, the Group has developed strong expertise in large and multinational organisations, for which it has implemented global solutions through specialist divisions and dedicated local and international teams.

Ranked globally as one of the largest staffing firms by Staffing Industry Analysts, the Group is also a global corporate member of the World Employment Confederation (formerly CIETT).

Company info
Website
Telephone
01707 247259
Location
Gi Group - Pharmaceutical Division
James Taylor House
St Albans Road East
Hatfield
Hertfordshire
AL10 OHE
GB

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