Head of Veterinary Regulatory Affairs
Head of Veterinary Regulatory Affairs
Our client a leading pharmaceutical manufacturer is recruiting for a Head of Veterinary RA. This role is based in Galway and is commutable from Tipperary and Clare. This is an opportunity to be part of a dynamic team within the Vet Regulatory Affairs function. In this role, you will report into the MD. You will be responsible to manage the Veterinary Regulatory affairs team and to achieve new marketing authorisations and maintain existing Marketing Authorisations in an efficient manner in line with company strategy. In addition, to act as the qualified person for pharmacovigilance (QPPV) for veterinary products.
- Maintain Existing Marketing Authorisations World-Wide
- 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 existing veterinary marketing authorisation worldwide
- Contribute to the development of the company 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 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:-
1. Identification and Out-sourcing of Animal Studies to Good Laboratory Practice (GLP)
2. Identification and Out-sourcing of Animal Studies to Good Clinical Practice (GCP) approved sites
3. Protocol design for Clinical / Bioequivalence / Tolerance studies
4. 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 company’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.
- Maintaining the company’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
Education, Skills and Experience required
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
- Ability to lead a team and manage diverse personalities and viewpoints.
- Ability to build relationships and collaborate with others is vital.
- Strategic decision-making within the business as an influencer.
- Being able to understand company finances, resourcing and ultimate aims of the business is important role modelling.
- Demonstrate and lead on the values, initiatives and culture of an organisation. Professional expertise.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Proven people management capabilities. Ability to motivate a team and collaborate cross-functional and across geographies
- Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
- Positive and proactive person who is energised by having great responsibility
- Practical, action-orientated approach to managing priorities and teams.
- Strong computer skills in MS Office
- Scientific qualification and background preferably B.Sc. or equivalent.
- Minimum 10 years in a FDA/CVM regulatory/R&D environment preferably with experience of generic applications. Knowledge of EU regulatory submissions would be an advantage.
- Experience in busy problem solving environment with the ability to work to tight deadlines and on one’s own initiative.
- Detailed technical knowledge of products and processes.
- Strong Customer Service focus both internally and externally
- Good command of technical English (both written and spoken)
- Ability to work on multiple projects simultaneously.
- Communication skills with external and internal customers.
For further information on this Head of RA role in Galway please contact Helga Reeves on 086 8168298 firstname.lastname@example.org
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