EU Veterinary Vaccine Regulatory Affairs Officer
- Experience Level
- Experienced (non-manager)
Predominantly remote working (home-based), with some European and International travel when required.
The successful candidate will report to the Regulatory Affairs Manager responsible for the EU/MENA (Middle East, North Africa) region.
- Provide regulatory support for the company’s veterinary vaccine portfolios in the EU/MENA region.
- Support all regulatory aspects of assigned projects associated with business objectives.
- Provide regulatory guidance in relation to new product development when needed. Prepare requests for scientific advice.
- Draft registration dossiers in formats suitable for submission in EU / MENA markets.
- Support all types of product lifecycle activities (renewals, variations, post authorisation commitments etc.).
- Preparation of responses for submission to regulatory authorities.
- Deliver high quality work to agreed timelines in order to effectively meet submission milestones.
- Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans.
- Establish and maintain effective working relationships with other Phibro regulatory affairs team members.
- Critically analyse complex data and present in a format appropriate to the audience.
- Maintain knowledge and awareness of emerging regulations/guidelines.
- Problem solving: propose and evaluate solutions to regulatory issues; prepare contingency plans.
Education & Experience:
Minimum of a Bachelor’s degree in a relevant scientific or veterinary discipline, but higher degree preferred.
Ideally five years of industry experience, and at least three years of experience in regulatory CMC.
Thorough knowledge of EU regulatory requirements (legislation/guidelines/Pharmacopoeia) is essential.
Experience with veterinary vaccines is preferred, but other candidates may be considered.
Proficient in written and spoken English. Additional language skills are a plus.
Experience in veterinary vaccine R&D / analytical assays / manufacturing are a bonus.
Team player essential – the work will involve close collaboration with RA colleagues and other business units.
Ability to handle several projects simultaneously, under minimal supervision.
Good organizational, prioritization and time management skills. Can work effectively under pressure.
Excellent attention to detail.
Proactive: foresee possible hurdles and propose solutions.
Manage and adapt to change.
Performance related bonus scheme
Scope to progress within the company over the longer term.