Position Details
Veterinary Regulatory Affairs Specialist
Location:
Predominantly remote working (home-based), with some European and International travel
when required.
Key requirements:
➢ Detailed knowledge and understanding of the EU and International Veterinary Medicines
regulatory framework.
➢ Strong technical expertise in product quality/safety/efficacy (able to understand, critique
and present information in a format appropriate to the audience)
➢ Previous experiences with vaccines developed by biotechnological processes such as
recombinant DNA technology and controlled gene expression.
Responsibilities:
➢ Provide regulatory support for the company’s veterinary vaccine portfolio.
➢ Support all regulatory aspects of assigned projects in accordance with the business
strategy, priorities and timelines.
➢ Establish and maintain effective working relationships with other PAHC business units
(Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated
into business plans.
➢ Provide regulatory guidance in relation to new product development when needed
(including review of study protocols and reports). Draft requests for scientific advice.
➢ Provide regulatory guidance in relation to technical transfer of manufacturing operations
between sites.
➢ Review and critique documentation intended for regulatory submissions to ensure relevant
regulatory requirements are met.
➢ Compile and draft registration dossiers suitable for global markets.
➢ Lead assigned projects to obtain and maintain licenses.
➢ Support all types of product lifecycle activities (draft and compile renewals, variations, post
authorisation commitments etc.).
➢ Draft responses to questions raised by regulatory authorities.
Education & Experience:
➢ Minimum of a Bachelor’s degree in a relevant scientific or veterinary discipline, but higher
degree preferred.
➢ Ideally at least five years’ experience as Regulatory Affairs in the Biology and vaccines
field.
➢ Proficient in written and spoken English. Additional language skills are a plus.
➢ Experience with veterinary vaccines (and products derived using rDNA technology) is
preferred.
Personal attributes:
➢ Self-starter, takes initiative.
➢ Team player essential – the work will involve close collaboration with RA colleagues and
other business units.
➢ Ability to handle several projects simultaneously.
➢ Good organisational, prioritisation and time management skills. Can work effectively under
pressure.
➢ Excellent attention to detail.
➢ Proactive: identify regulatory risks and propose solutions.
➢ Demonstrate integrity.
➢ Confident in communicating with regulators
Opportunities:
Scope for progress within the company over the longer term
To learn more about Phibro Animal Health's competitive benefits package, please click here: .