Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

Remote type: Daljinsko

Locations: Palo Alto, CA, USA

Time type: Polni delovni čas

Posted on: Objavljeno danes

Job requisition id: R1991

Povzetek delovnega mesta

Support the North America food regulatory work for Food Biosciences, Grains Processing, and Cultures. The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U.S. and Canada. This role involves regulatory document development and compilation for registration/market access as well as pre- and post-launch compliance activities with a focus on our Food Biosciences business (i.e., food enzymes and cultures) and Grains Processing (food carbohydrate processing enzymes) portfolio.

Job Responsibilities:

• Responsible for management of the food businesses portfolio.
• Draft submissions such as US food GRAS (self-GRAS and FDA GRAS Notifications) and Canadian food additive submissions for food enzymes and cultures.
• Serve as a point of contact for the food businesses and global regulatory strategy leaders.
• Conduct monthly calls with the North American Market Regional Industry Leaders to communicate the status of submissions and prioritization of regulatory work.
• Provide regulatory guidance for food related research and development teams.
• Lead food related North America advocacy work as IFF and through trade associations such as the Enzyme Technical Association.
• Possible regulatory support to non-food businesses and/or other regions.
• Potential non-food businesses include Home and Personal Care and Animal Nutrition.
• Contribute to global regulatory compliance programs for IFF marketed products in conjunction with global GRA team and product management.
• Update Registration List to communicate the status of the US and Canadian regulatory projects, participate on GRA calls and working groups related to global regulatory work.
• Participate in projects regarding improving regulatory processes within GRA.
• Upload and maintain documentation and improve documentation of U.S. and Canadian work.

Job Requirements:

• Bachelor’s degree in Biology or a closely related scientific field and at least 7-10 years of experience in several aspects of the regulatory processes.
• Background in biology or a related field is required to understand both general food technologies as well as the biological basis for assessing the safety and efficacy of our enzymes and other biological products.
• This involves knowledge of acute toxicology, fate of the bioproducts in the digestive tract, and exposure to humans.

Additional experience requirements include:

• Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/scientific papers, risk assessments).
• Experience successfully impacting product introductions by providing regulatory & safety guidance and/or successfully influenced decisions to implement change.
• Experience in interaction with and education of regulatory agencies and trade associations and track record in product clearance/registrations and regulatory advocacy.
• In-depth knowledge and recognized for leadership & innovation in managing regulatory submissions to US FDA and Health Canada.
• Successfully implemented complex/controversial regulatory policies and strategies, and/or systems to improve regulatory data communication.
• Demonstrated influence on the department (can be in non-technical/scientific manner) and/or strong impact on the success of future products and processes.
• Demonstrated continuous learning mindset and flexibility to expand expertise into new industries, applications, and jurisdictions.

Salary Range: $107,000.00 - $160,400.00