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Job Details

Senior Regulatory Affairs Manager, OTC

Company: Key People Limited
Location: East London
Reference: 1603-103
Closing Date: 08 Dec 16
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: bonus and benefits

Job Summary:

An excellent opportunity has arisen for a Senior Regulatory Affairs OTC Manager to join one of the largest Pharmaceutical companies in the world. This role has become available due to growth within the company and the ideal incumbent will have a background in OTC products (maintenance and compliance) and previous line management exposure.

Requirements:

An excellent opportunity has arisen for a Senior Regulatory Affairs OTC Manager to join one of the largest Pharmaceutical companies in the world. This role has become available due to growth within the company and the ideal incumbent will have a background in OTC products (maintenance and compliance) and previous line management exposure.

Experience Required:

• You will be educated to BSc (Hons)
• Manager level or equivalent with excellent OTC regulatory knowledge.
• Extensive experience in the registration of OTC products (ideally human medicinal) in the EU and other international markets, plus previous line management will be required to
be considered for this role.

Main Responsibilities:

• Manage the OTC Maintenance & Compliance team, ensuring all key milestones are met
• Prepare and manage variations and renewals, coordinate submission of renewals and change control requests
• Coordinate the preparation and conduct the review of responses to questions raised by the regulatory authorities
• Deputise for the Associate Director of the Maintenance & Compliance Team when required
Develop and implement regulatory strategies, enabling the routine maintenance activities for approved marketing authorisations to meet regional and country requirements
• Performance management, ensuring high quality regulatory dossiers are submitted and responses to the Health Authority are in accordance to standards and legislation
• Work closely with joint venture OTC RA teams, ensuring registered information flows readily to and from central RA

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons:

> We achieve results faster
> Our candidates really are a cut above
> We add greater value

We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.

Apply for this job: Senior Regulatory Affairs Manager, OTC

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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