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 pharmacovigilance
- Manage 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 fees
- Provide 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 industry
- People management experience at a senior level
- Experience of the regulatory landscape of the market, and industry competitors
- Experience in working with UK & European legislation, licencing, and pharmacovigilance.
- Experience in a strategic role and in a senior leadership role.
- Budget management experience
Benefits include bonus, car allowance, pension, medical/dental insurance, life assurance and hybrid working.