Team Manager

il y a 1 semaine

Libourne, France CEVA Animal Health, LLC Temps plein

**Team Manager - Regulatory Affairs Procedures, Europe Zone**

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.

**Your missions**:
As part of Ceva Santé Animale's global strategy to develop and defend its pharmaceutical products, the European Zone Regulatory Affairs Procedures Manager works closely with R&D, Regulatory Affairs, support functions (Supply, DTP, Industrial, etc.) and Marketing.

Reporting to the Head of Regulatory Affairs Pharma Procedures within the I&D Department, he/she will carry out the following tasks:
**Portfolio management**:

- In collaboration with the regulatory teams responsible for drafting the Quality, Safety and Efficacy sections, you will define and implement the regulatory strategy for MA dossiers in the countries in your geographical area for Ceva's pharmaceutical products in order to ensure compliance with the regulations for the development, registration and maintenance of MAs.
- You will be responsible for preparing, communicating (to the Franchises and Operations in the countries) and coordinating the registration, maintenance and defence programmes for Ceva's 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 Representative**:

- 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 manager**:

- 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.

**Your 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.

**Hard skills**:

- Solid strategic and technical knowledge of regulatory affairs, with a global and long-term vision.
- Experience in leading major submissions (e.g. EMA, USFDA) is a plus.
- Ability to manage and coordinate complex projects.
- Ability to negotiate effectively with different types of interlocutors, including the authorities.
- Ability to manage stressful situations with internal and external stakeholders.
- Promoting new regulatory initiatives internally.
- Demonstrate exemplary leadership and ensure ethics and transparency within the department.
- Master the art of scientific language in English (both oral and written).

**Soft skills**:

- Organised and rigorous
- Be solution and customer oriented.

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