Head of Regulatory Affairs - Biologics

Description

Position Summary：

Provide leadership for regulatory affairs to VMRD China for local development and selected imported registration projects to ensure compliance with MARA requirements and Zoetis' standards. Responsible for the development and implementation of robust regulatory strategies to support the regulatory efforts in China. Ensure regulatory compliance in all aspects of the function. As a Member of the VMRD China Leadership Team and part of the global regulatory network, provide input/insights to contribute to the agility, efficiency and outcomes of the Zoetis organization.

Essential Duties and Responsibilities：

• Lead all regulatory affairs activities for VMRD China, build a high performing regulatory team and coach team members to enhance their personal development.

• Ensure protocols/reports meet MARA/IVDC regulations, prepare and submit high quality dossier/supplementary documents to MARA/IVDC, coordinate and address queries raised by the regulatory authorities.

• Work across teams (locally and globally) to define and execute robust regulatory strategies ultimately leading to the registration and commercialization of new products.

• Engage Project Team members, and global VMRD experts to leverage global know-how and build on local regulatory expertise to deliver outcomes consistent with project plans.

• Provide regulatory assessments and advice to all phases of biologics projects development, identify gaps and conduct gap analysis with project teams in a systematic manner to ensure swift progress of MARA regulatory reviews.

• Ensure regulatory compliance in all aspects of the function.

• Develop colleagues for succession plan.

• Develop strong working relationships and act as a primary interface with the global VMRD organization and the local regulatory agencies.

• As a Member of the VMRD China Leadership Team and part of the global regulatory network, provide input/insights to contribute to the agility, efficiency and outcomes of the Zoetis organization.

Requirements (if applicable)：

• MS or Ph.D degree from relevant field with at least 10 years of professional experience in Biologic research & development.

• Sound knowledge of the China regulatory requirements and legal framework for new technology, and Bio/Pharma veterinary medicinal products and of industry trends; self-motivated with demonstrated leadership skills; record of achievement in area of responsibility and demonstrated success in interactions with regulatory authorities.

• Good communication, negotiation and organizational skills; strong team player; proficient in written/oral English communication; ability to efficiently work across lines.

• Demonstrate innovative thinking and promote creative solutions across Teams.

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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