Compass Life Sciences have been engaged to support an exciting and internationally renowned Pharmaceutical company that operates within both human and animal health. As a leading manufacturer and distributor of generics medicines they have a global footprint and are continuing to offer highly innovative medicines across over 90 countries whilst doubling company revenues over the past 5 years. Our client is seeking a Head of Regulatory Affairs to lead the Veterinary Regulatory affairs team.
Reporting direct to the MD, this is both a tactical and strategic role with broad responsibilities for driving new MAs and maintenance of existing MAs to support the company strategy. In addition to this, you will act as the qualified person for Pharmacovigilance (QPPV) for veterinary products.
The functions of the Head of Veterinary Regulatory Affairs include but are not limited to the following:
- Design product-specific regulatory programmes and agree priorities and time schedules in conjunction with the management team
- Organise and lead the submission and approval of new products via national, mutual recognition, decentralised and centralised procedures
- Manage the maintenance of all the client's existing veterinary marketing authorisation worldwide
- Contribute to the development of the client's Group by active participation at Management level
- Organise and co-ordinate appropriate resources to meet the demands of the Regulatory Programme as agreed with Managing Director/senior management team
- Manage The client's Veterinary Regulatory affairs team and provide advice to R&D in relation to regulatory requirements for veterinary products
- Manage all elements of external studies including:
- Identification and Out-sourcing of Animal Studies to Good Laboratory Practice (GLP)
- Identification and Out-sourcing of Animal Studies to Good Clinical Practice (GCP) approved sites
- Protocol design for Clinical / Bioequivalence / Tolerance studies
- Communication with study directors responsible for out-sourced trial work
- Liaise with regulatory bodies within Europe and with appointed agents in other countries
- Negotiate win/win situations with regulatory bodies on issues that arise during assessment.
- Communicate with colleagues in joint ventures companies
- Review regulatory issues in Contracts, Secrecy Agreements and Sales and Distribution Agreements
- Keep up to date with changes in global regulatory requirements
- Provide technical support to in-house sales team, sales representatives customers
- Co-ordinate the registration and searches for Patents and Trademarks for the client's products
- Identify training needs within the department and implement appropriate training plan.
- Review and approve change control requests with a view to their impact on regulatory compliance and product stability and follow up on any consequential regulatory and/or stability actions.
Qualified Person for Pharmacovigilance
- Maintaining the client's veterinary Pharmacovigilance system
- Conducting continuous overall Pharmacovigilance evaluation during the post authorisation period of products
- Managing of the provision to the NCAs or the Agency of any other information relevant to the evaluation of the benefits and risks of a VMP
- Managing the Logging, investigating and reporting of Pharmacovigilance complaints received
- Managing the Preparation of Periodic Safety Update Reports for submission to Regulatory authorities in relation to national, MRP, DCP and centrally approved Marketing Authorisations
- Managing the submission of expedited reports when necessary
- Managing the maintenance of Pharmacovigilance systems (CRF's PSUR data base, Line Listings)
- Collation of Pharmacovigilance data received from sub licensees
- Provision of Pharmacovigilance data to sub licensees
- Handling of requests for information from competent authorities,
- Handling of urgent safety restrictions and Submission of safety variations
- Remain informed with current Pharmacovigilance requirements.
- Reviewing Pharmacovigilance sections in Contracts and Agreements with third parties
- Identifying training needs for Pharmacovigilance and implementing appropriate training plan.
- Oversight of quality control and assurance procedures within the Pharmacovigilance system
- Oversight of SOPs within the Pharmacovigilance system
- Oversight of compliance data in relation to the quality, completeness and timelines for expedited reporting and submission of PSURs within the Pharmacovigilance system
- Oversight of Pharmacovigilance audit reports
To be considered for this role, our client is looking for an exceptional Regulatory professional with a proven track record working in a leadership position overseeing Veterinary R&D and approved products. They are looking for leaders that are able to manage diverse personalities and perspective, and that can build relationships collaboratively. You will need to be a strategic decision-maker within the business as an influencer whilst having a firm grasp of the business structures around company finance, resourcing and strategic delivery.
In addition to this our client is looking for significant experience within the FDA/CVM regulatory/R&D environment preferably with experience of generic applications. Knowledge of EU regulatory submissions would be an advantage. A scientific qualification and background preferably B.Sc. or equivalent is required.
To apply, or request further information please contact David Jolley at [email protected] or phone +44 (0)7738 586 627.
Compass Life Sciences are a trading name of Compass Associates Ltd, and are acting as a recruitment consultancy for this permanent vacancy.