Regulatory Affairs Manager M/F

Regulatory Affairs Manager M/F

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.  

Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.  

As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team. 

 

Your
missions :

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.