Regulatory Affairs Team Lead - Europe

Irving Knight Group; Bordeaux; Sur place; EUR 65 000 - 80 000; Plein temps

Résumé du poste

A leading company in the animal health sector seeks a Regulatory Affairs Team Lead to oversee regulatory strategies and manage a team in Bordeaux. The ideal candidate will have extensive experience in veterinary drug registrations and a strong educational background in Pharmacy or related fields. This role offers a competitive salary package, relocation assistance, and the opportunity to contribute to the digital transformation of the department.

Qualifications

• At least 7 years' experience in veterinary drug registrations.
• Experience in providing strategic regulatory advice for global product development.
• Initial team management experience is a plus.

Responsabilités

• Collaborating with regulatory teams for MA dossiers.
• Preparing and coordinating registration and defense programs.
• Managing a team of 4 and implementing regulatory strategies.

Connaissances

Regulatory Strategy

Team Management

Regulatory Compliance

Communication

Formation

Degree in Pharmacy, Veterinary Regulatory Affairs, or related field

Description du poste

Job Title: Regulatory Affairs Team Lead - Europe

Location: Bordeaux, France (onsite min. once/week) - relocation assistance offered

Package: €65,000 - €80,000 + company performance-based bonus + additional benefits

Reporting to: Head of Regulatory Affairs, Pharma Procedures

Irving Knight is currently partnered with a global leader in the animal health field, committed to developing solutions to ensure the highest level of care within livestock (poultry, pigs, ruminants), companion animals, and wildlife.

The role involves:

1. Collaborating with regulatory teams responsible for drafting the Quality, Safety, and Efficacy sections to define and implement the regulatory strategy for MA dossiers across your geographical area, ensuring compliance with regulations for development, registration, and maintenance of MAs.
2. Preparing, communicating (to Franchises and Operations in the countries), and coordinating registration, maintenance, and defense programs for the pharmaceutical portfolio by drawing up submission schedules, liaising with local Regulatory Affairs teams and Authorities, and collaborating internally.

Regulatory Affairs Responsibilities:

• Representing regulatory affairs for products in development within the European zone and acting as the spokesperson for the International zone where applicable.
• Serving as the contact point for regulatory authorities.
• Participating in trade association working groups.
• Developing and maintaining regulatory expertise in your geographical area, staying updated with local regulation changes.
• Managing a team of 4 responsible for the zone, planning and implementing regulatory strategies.
• Contributing to departmental performance improvements and raising its profile within the company.
• Developing colleagues' skills.
• Participating in the digital transformation of the department.

Ideal Profile:

Degree in Pharmacy, Veterinary Regulatory Affairs, or related field in Chemistry, Pharmacy, or Regulatory Affairs, with at least 7 years' experience in veterinary drug registrations and biotech product development.

Experience in providing strategic regulatory advice for global product development at all stages, including marketed products, and conducting meetings with regulatory authorities. Initial team management experience is a plus.