Head of Regulatory Affairs
Salary:-Negotiable
Location:- London
Employment type: - Perm
This company are a forward thinking Pharmaceutical company who are currently looking for a Head of Regulatory Affairs and are experiencing extensive growth throughout all of their product areas. Joining an established Regulatory team the Head of Regulatory will be responsible for leading and motivating a large regulatory affairs division.
Key Responsibiliites:
* Provide effective leadership to Regulatory Affairs to constantly deliver high quality outputs
* Work with Sales, Marketing and Medical and Regulatory Affairs Leadership Team to share successes and identify/resolve issues
* Responsible for the recruitment and retention of high calibre staff
* Accountable for managing the Regulatory Affairs budget within agreed limits and according to phased targets
* Act as the external liaison representing the company in key contacts with professional bodies such as MHRA, IMB, ABPI and TOPRA
* Understand and promote UK/Irish/Malta business needs into European strategies and decisions on drug development and regulatory filings/issues
* Build and maintains long-term, industry-leading relationships with the MHRA and IMB/ MA
* Ensure that clinical trial applications are filed to target, and varied and renewed to remain in compliance
Minimum skills and Requirements:
* Life sciences degree or appropriate professional qualifications
* Extensive regulatory experience in the pharmaceutical industry or with a regulatory agency, with some time spent in a commercially aware business role
* Clear and proven experience of people and performance management
* Track record of successful negotiating with Regulatory Agencies
* Experience of operating at a strategic level in the business
Keywords:- Regulatory Affairs, Regulatory, Head of Regulatory Affairs, Regulatory Affairs Director, pharmaceuticals, people management, Uk, Ireland, Clinical , European, EU, clinical trial applications, strategy, MHRA, NICE, ABPI, London, South West, Hertfordshire, Surrey, Middlesex, Hampshire, Berkshire, Bedfordshire, Buckinghamshire
We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk
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