Regulatory Affairs Specialist

Phibro is hiring Veterinary Regulatory Affairs Specialist, for Beit Shemesh site, Israel.

It could be remote working (home-based) or on site, with some International and European travel when required.

Reporting to the global CMC Regulatory Affairs Manager.

Key requirements:

1. Detailed knowledge and understanding of the international and European Veterinary Medicines regulatory framework and guidelines.
2. Strong technical expertise in product quality/safety/efficacy
3. Scientific regulatory writing

Responsibilities:

1. Provide regulatory support for the company’s veterinary vaccine portfolio.
2. Support all regulatory aspects of assigned projects in accordance with the business strategy, priorities and timelines.
3. Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans.
4. Provide regulatory guidance in relation to new product development when needed (including review of study protocols and reports). Draft requests for scientific advice.
5. Provide regulatory guidance in relation to technical transfer of manufacturing operations between sites.
6. Review and critique documentation intended for regulatory submissions to ensure relevant regulatory requirements are met.
7. Compile and draft registration dossiers suitable for global markets.
8. Lead assigned projects to obtain and maintain licenses.
9. Support all types of product lifecycle activities (draft and compile renewals, variations, post authorization commitments etc.).
10. 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.
• At least five years of pharmaceutical industry experience, including experience in regulatory CMC (Part 2 – Quality).
• Proficient in scientific written and spoken English. Additional language skills are a plus.
• Ideally experience with veterinary vaccines and/or products derived using rDNA technology.