Regulatory affairs team lead - europe

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


Responsibilities:

Portfolio Management

* Collaborating closely with regulatory teams responsible for drafting the Quality, Safety and Efficacy sections, to define and implement the regulatory strategy for MA dossiers in the countries in your geographical area for the organisation's pharmaceutical products (ensuring compliance with the regulations for the development, registration and maintenance of MAs).
* Responsible for preparing, communicating (to the Franchises and Operations in the countries) and coordinating the registration, maintenance and defense programs for the portfolio of pharmaceutical products by drawing up submission schedules, liaising with the local Regulatory Affairs teams and the Authorities and collaborating with internal departments.


Regulatory Affairs

* You will be the regulatory affairs representative for products in development for the European zone, and the spokesperson for the International zone where applicable.
* You are the contact for the regulatory authorities.
* You take part in trade association working groups.
* You will develop Regulatory Expertise in your geographical area, and keep it up to date with changes in local regulations.


Team Leader

* You will manage a team of 4 people responsible for the zone and will be responsible for planning and implementing the regulatory strategy.
* You will help to improve the department's performance and raise its profile within the company.
* You will develop your colleagues.
* You will be involved in the digital transformation of the department.


Ideal Profile:

Degree in Pharmacy or Veterinary Regulatory Affairs or equivalent in the field of Chemistry, Pharmacy and/or Regulatory Affairs, with at least 7 years' experience in veterinary drug registrations with experience in Biotech product development.


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