Regulatory & Quality Director

Posted 22 May 2024
Salary
£110000 - £120000 per annum + Bonus, Car Allowance, Medical, Hybrid
Location Leatherhead
Job type Permanent
Discipline Risk & Compliance
Reference JE/77712152_1716393142
Contact Name Joanna Engel
Global Healthcare Company currently seeks a Regulatory & Quality Director to join their team based in Surrey. The Regulatory & Quality Director leads a team of technical, regulatory, and quality specialists, to ensure compliance for all regulated activities. This is a broad remit which includes responsibility for government relations, issue management, corporate and social responsibility, strategic communications, and information distribution.The Regulatory & Quality Director is the named person on all external regulatory licenses and external pharmaceutical, regulatory and government bodies.Core responsibilities for the Regulatory & Quality Director include:Review and sign off the compliance of all advertising and promotional pieces and provide input on media coverage.Assure handling of external customer enquiries and complaints regarding compliance with national and adverse drug event recording and reporting guidelines for pharmacovigilanceManage the holding and distribution of our product's regulatory information.Maintain comprehensive knowledge of industry, regulatory, quality, pharmacovigilance and legislative changes and developments. Keep internal processes adherent to UK regulations and aligned with global standards.Own the regulatory strategy for all our products, identifying opportunities for changes to licence conditions.Manage the renewal and variation of licences for all in-line products in the UK. Draw on knowledge of legislation and licensing practice to achieve issue of an amended licence.Provide information on our products licences to internal and external groups.Manage overall strategies and representation on cross-industry and government liaison bodies; NOAH, Animal & Plant Health Agency (APHA)Be the named person, signatory, and holder responsible for compliance on Animal Health's Wholesale Dealer's Licence, drug licence, pharmacovigilance reporting in the UK.Develop the Op plans for the business unit annually.Manage the Regulatory and Technical team budget. Project funding for product licence applications, annual fees of regulatory bodies and trade association feesProvide to your direct reports, a specific and clear direction for the strategy, objectives, policies, practices, and expectations within the business unit.Ad-hoc projects.Requirements for the Regulatory & Quality Director include:MRCVS or other relevant post graduate qualification is required.Holds membership of The Organisation for Professional Regulatory Affairs (MTOPRA) or Registered (experienced) with the same body (MTOPRA - reg)Significant experience in Regulatory Affairs in Animal Health industryPeople management experience at a senior levelExperience of the regulatory landscape of the market, and industry competitorsExperience in working with UK & European legislation, licencing, and pharmacovigilance.Experience in a strategic role and in a senior leadership role.Benefits include bonus, car allowance, pension, medical/dental insurance, life assurance and hybrid working.Follow us on social media for updates on our latest opportunities, market trends and what it's like to work with us.
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