Regulatory Affairs Manager

In order to reinforce our Global RA Team, we are looking for a RA Manager M/F.

The role involves significant complexity in having to address local operational issues to global and interact with many individuals within the regulatory, business and logistic groups in order to meet the business unit needs and regulatory compliance.

The RAM has as primary task to take care of the Regulatory Affairs (RA) activities of Ceva’s veterinary medicinal products, to maintain product and manufacturing sites authorizations to ensuring business continuity and monitor RA compliance against internal and external regulations and requirements.

This includes the management of product registration activities and manufacturing site regulatory authorizations, in accordance with corporate policies, local regulatory requirements and strategic direction of the business unit under your responsibility.

More specifically, product registration activities relate to:

- The regulatory life cycle management of a group of product registrations,
- The preparation of the new technical registration files, in collaboration with R&D, manufacturing, Quality Control, Quality Assurance and Marketing teams,
- The submission of dossiers to the relevant local authorities and the follow-up of the corresponding procedures.

In addition, the RAM has controlling, guiding and advising tasks in activities that are directly or indirectly related to the registration of its products portfolio. Properly weighing and managing the associated business risks is crucial. The RAM advises business on any new regulatory opportunities or risks arising in the RA environment to allow business to realize growth opportunities or avoid losses.

The RAM participates to develop proactively and maintain relations with the authorities responsible for regulatory affairs in the countries of his areas of responsibility, has contact with stakeholders inside and outside the company, defends the interests of the company in compliance with the requirements of the law and legislation and the business principles of the company.

**Your profile**:
You have a degree in veterinary medicine or pharmacology or a master's degree in biology with additional training in regulatory affairs. Ideally, you will already have experience (5-10 years) in the field of immunological veterinary medicinal products.

You are fluent in English. You are a dynamic person who likes challenges and would like to join an international company.

The position will be based in Angers, with the possibility of remote work.