Regulatory Affairs Director

Description

Position Summary:

He/She will be responsible for the Regulatory Affairs (RA) Department and, in agreement with the General Manager, Leadership Team and internal EU Regulatory Functions, defines regulatory strategies for veterinary medicinal products and diagnostic in Italy.

This role involves ensuring compliance with all relevant Italian and EU regulations and guidelines, working closely with regulatory agencies, internal teams, and external partners to achieve regulatory approvals and maintain compliance throughout the product lifecycle.

In line with the company guidelines and in coordination with the General Manager and internal EU Functions, he/she promotes positions favorable to the company.

He/She supervises the local functions included in the RA Department (Regulatory, Artworks, Marketing Compliance, Pharmacovigilance and Quality) providing strategic and decision-making support, to ensure correct management of activities based on current legislation, guidelines and notes issued by the competent authorities and in line with the company objectives.

Main Responsibilities/Activities:

- Head of the in-country Regulatory Affairs team, coordinates the Regulatory Affairs Managers’ (RAM) activity based on their product portfolio and skills.

- Supports the RAMs' Regulatory activity (in particular those that are non-routine or that present aspects of particular relevance or complexity) by providing strategic and decision-making guidance.

- Ensures correct management of regulatory activities by contributing to the maintenance of products on the market and the registration of new products in coordination with the internal EU Functions and in compliance with local and EU regulations and company planning.

- Provide regulatory guidance to cross-functional teams, including R&D, clinical, and commercial teams.

- Serves as primary contacts with the Competent Authority, managing personally key projects and strategic communications.

- Serves as primary contacts with the internal European Functions which assists in planning EU activities with local impact and in assessing and resolving any issues.

- Proactively identifies regulatory issues that may impede the regular supply of products, proposing and managing contingency plans for a timely resolution with ad hoc teams.

- Supervises the local “Artwork” function, providing strategic and decision-making support, and ensuring that processes are in place to ensure compliance of artworks with the texts approved by the competent authorities.

- Supervises the “Pharmacovigilance” function, providing strategic and decision-making support and ensuring that the “Local Responsible Person for Pharmacovigilance/LRPPV” is adequately supported and trained in order to fulfill his/her responsibilities.

- Supervises the local “Quality” function, providing strategic and decision-making support and ensuring that the Affiliate Quality is adequately supported and trained in order to fulfill his/her responsibilities.

- Supervises the “Marketing Compliance” function, providing strategic and decision-making support and ensuring proper management of activities in accordance with current legislation, guidelines and notes issued by the competent authorities in order to ensure compliance of informative and promotional materials.

- Organizes a system at local level to ensure revision of promotional materials with what is authorized in compliance with local regulations and the "Animal Health Industry Association" self-regulation code.

- He/She is a member of the Leadership Team. He/She ensures adequate support for local and regional company projects by providing both strategic and tactical indications for the areas of his/her competence, ensuring compliance and inspired by continuous improvement.

- He/She promotes the expression of the Core Beliefs and takes care of the organizational model of his team to improve its efficiency and promote initiatives for the development of talents.

Qualifications and Skills:

• Degree in Veterinary Medicine or Chemistry and Pharmaceutical Technology, Chemistry, Pharmacy, Biology
• At least 10 years of experience in the regulatory field, of which 5 preferably in the veterinary medicines sector.
• In-depth knowledge of local and EU Regulations and guidelines; and a solid knowledge of European and national regulatory processes, experience in managing regulatory projects
• Knowledge of the veterinary medical devices, in-vitro veterinary diagnostics, point-of-care offerings and rapid test sector, is considered a plus.
• Demonstrated practical experience in leading, managing and preparing applications/variations.
• High standing, with excellent communication and negotiant skills
• Excellent knowledge of spoken and written English.

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Diversity, Equity & Inclusion

Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.

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