The Senior Regulatory Manager Vaccines is an integral member of the regulatory affairs team, leading registration of selected portfolio of veterinary medicinal products for the global marketplace. This role has a speciality in vaccine development and registration and provides training and leadership to other members of the regulatory team. This role provides support to the Regulatory Affairs Director and advises the R&D department on the development of veterinary vaccine products to gain registrations in the EU, USA and other important global markets. The role requires the preparation and submission of regulatory dossiers and the maintenance of existing products. The Senior Regulatory Manager Vaccines reports to the Regulatory Affairs Director.
- Leading the registration of key veterinary vaccines from the Benchmark portfolio in the EU, USA and other important global markets, with clear communication of and adherence to timelines
- Development of regulatory registration strategies for veterinary vaccines to provide guidance to R&D on the key regulatory studies required for registration
- The supervision of the preparation of e-dossiers and submission documentation for the registration of veterinary medicinal products globally
- Life cycle management of registered veterinary medicinal products (variations and renewals)
- Providing key advice, guidance and training to other regulatory staff on veterinary vaccines
- Provide regulatory intelligence in key regulatory environments
- Provide input into the development of regulatory systems and documentation management
- Interfaces with multi-disciplinary technical teams on the progress of regulatory aspects of R&D projects
- Communicates ideas for improving company regulatory processes with a positive and constructive attitude, and for developing this attitude in others
Qualifications and experience:
- A broad depth of experience in regulatory affairs within the animal health sector essential
- A proven track record in the registration of veterinary medicines in the EU and/or other key global markets
- Experience in veterinary vaccine registrations essential
- Knowledge of the European registration routes (centralised, DCP and MRP) a requirement
- Knowledge of FDA and/or USDA registration an advantage
- Educated to degree level in biological sciences. A higher degree or specific relevant work experience highly desirable
- Previous experience in research or development would be an advantage
- Knowledge and understanding of product development processes and knowledge of GCP, GLP and GMP would be an advantage
- Advanced PC skills including Microsoft Project, Word, Excel, Powerpoint
- Demonstrable ability to work effectively in a fast paced, rapidly changing technology environment and to work on multiple work streams and projects simultaneously.
- Excellent verbal, written and presentation communication skills with experience in project reporting.
- Strong interpersonal skills and proven ability to communicate and collaborate effectively with senior management and across multidisciplinary teams.
- Ability to build and develop relationships at all levels
- A self-starter comfortable with working with colleagues in a variety of international locations
- Self-motivated and autonomous with effective time management abilities
- Flexible and able to travel nationally and occasionally internationally as required
To apply, please send a CV and covering letter to Rob Squirrell at firstname.lastname@example.org. Closing date: 31 October 2019