The successful candidate will be responsible for the planning, design and implementation of our regulatory strategy and will:
- Lead a team of Regulatory Affairs officers and associates, and manage external regulatory consultants
- Provide regulatory strategy for planned submissions in EU, US and other geographies for the life-cycle management of in-line brands and for new products
- Work in partnership with R&D project leaders to provide clarity on regulatory pathways for the registration of new veterinary products.Drive and lead consultation with regulatory authorities when required
- Assist with the design and development of company regulatory procedures
- Prioritise, plan and budget for regulatory projects in accordance with company and regulatory requirements
- Be the interface between the company and the regulatory authorities. Request, organise and attend meetings with regulatory authorities
- Coordinate the preparation of submissions to the regulatory authorities and ensure submissions are aligned with the timelines agreed with the business
- Control and assure the quality of the scientific and material content of submissions to regulatory authorities. Oversee the publishing and dispatch of submissions to regulatory authorities.
- Review documentation and prepare registration dossiers, including summary documents. Prepare and review SPC and labelling. Check and sign label mock ups and artworks. Review documents prepared by others in the team.
- Keep up to date with pertinent scientific and technical information and maintain a high level of regulatory knowledge on current procedures and regulations that are relevant for the company
- Serve as a mentor to junior staff and provide training related to the statutory regulation and approval systems and processes
Experience and Skills
- A life sciences degree is required
- Relevant experience in the pharmaceutical industry (minimum 5 years)
- Experience with the registration of veterinary vaccines highly desirable
- Clear communication in written and spoken English.
This is an excellent opportunity to join a financially successful company, headquartered in North London. We are offering a competitive salary and benefits package that includes private health insurance, performance related bonus and share options.
To apply or to speak to the recruitment manager, please email email@example.com or call +44 20 8447 6909.