APAC Regulatory Approvals Manager

Fengxian, Shanghai
Permanent
Full-time

1 month ago

Job Description:Innovation to deliver novel nutritional solutions for cats and dogs is a key driver of growth for Royal Canin. The Global Regulatory Affairs function maximizes opportunity & minimizes risk by guiding business decisions based on scientific & regulatory insight to ensure the freedom to launch these new innovations. The Regulatory Approvals Manager will develop and implement the regulatory strategy for novel ingredients and products to ensure successful and timely launch in APAC markets like China and Korea. This role will work closely with the global R&D and Commercial teams to design appropriate studies and prepare regulatory submissions. The regulatory approvals manager will also interact with government officials to clarify and detail the data submitted to support regulatory submissions. This role will collaborate across functions and with ingredient suppliers to prepare, file, and track regulatory submissions.What are we looking for?5 years, ideally 10y of experience in Regulatory Affairs or related field. * Ph.D. or equivalent in a technical area, such as food science, veterinary medicine, microbiology, genetics, chemistry, toxicology, nutrition, or other biological science.

Excellent knowledge of Regulatory Dossiers in feed nutrition, ingredients, pet food law, regulatory and scientific stakeholders.
Strong written and verbal communication skills required to develop regulatory dossiers and communicate complex scientific data clearly and concisely.

What will be your key responsibilities?

Anticipates which ingredients will require specific regulatory authorizations in APAC markets (with a priority being given to China) to secure market access continuity and to enable the launch of innovative formulations
Define regulatory dossier approval strategy in collaboration with R&D, Commercial, and global regulatory approval colleagues.
Lead and manage the process for obtaining regulatory approvals for new and existing products.
Design regulatory studies to ensure they meet regulatory requirements and partner with R&D and ingredient suppliers to complete the required studies.
Oversee the preparation and submission of all necessary documentation and information for regulatory approval submissions and be responsible for the drafting of the master technical file.
Build relationships with regulatory agencies and maintain open communication to ensure timely and accurate responses to inquiries and requests.
Ensure organization has a full understanding of who the regulatory approval requirements will impact overall project timelines and resources
Continuously improve and streamline processes related to regulatory approvals.
Maintain accurate and up-to-date records and documentation related to regulatory approvals
Defines the partnerships and associated budgets with suppliers and consultants.
Provide information, contributing to the monitoring of emerging trends and regulations in the industry through engagement in trade associations and regulatory/compliance monitoring.

What can you expect from Mars?

Work with diverse and talented Associates, all guided by the Five Principles.
Join a purpose driven company, where we’re striving to build the world we want tomorrow, today.
Best-in-class learning and development support from day one, including access to our in-house Mars University.
An industry competitive salary and benefits package, including company bonus.

Mars

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