Director of Regulatory Affairs

Our client belongs to the food production industry who is cultivating the future of sustainable seafood by crafting delicious, nutritious, affordable cultivated fish that is better for the health, the oceans, and our planet. They are weaving together the deep wisdom of the oceans with modern innovation to develop reasonable and healthy seafood that provides a sustainable alternative to the harmful impact of traditional fishing practices.

Responsibilities:

• Develop and Execute Global Regulatory Strategy: Lead the development of a comprehensive global regulatory strategy for cultivated seafood products. This includes deep analysis of existing frameworks, anticipation of future regulatory developments, and proactive engagement with regulatory bodies in key markets.
• Navigate Complex Landscape: Stay abreast of the evolving regulatory landscape across different countries and regions, identifying potential challenges and opportunities for product approvals.
• Internal Regulatory Expert: Lead internal strategy around development of theory of safety, definition of required supporting data, and coordination of internal team resources to support regulatory advancement. Advise cross-functional teams on regulatory considerations, ensuring compliance throughout product development, manufacturing, and commercialization.
• Lead Regulatory Submissions: Direct the preparation and submission of high-quality regulatory dossiers (e.g., novel food applications, pre-market notifications) in collaboration with internal and external stakeholders.
• Stakeholder Engagement: Build strong relationships with key regulatory agencies, industry associations, and relevant government bodies globally. Facilitate discussions with strategic suppliers and customers to help them understand our regulatory requirements and their roles in implementation. Foster collaborative dialogue to advocate for science-based regulatory approaches.
• Contribute to Regulatory Landscape: Participate in industry working groups and policy discussions to shape the future of cultivated meat regulations.
• Drive Continuous Improvement: Stay informed of the latest scientific advancements and regulatory trends. Recommend updates to the company's regulatory strategies and best practices.

Requirements:

• 5+ years in highly regulated fields, especially novel foods
• Experience with dossier prep and novel food approval across multiple global jurisdictions
• Familiarity with regulatory frameworks in several key markets, including US, EU, China, and Japan (preferred)

Skills

• Highly-skilled technical communicator – able to translate internal science-based evaluations to regulators in a clear, understandable, and persuasive manner and translate regulatory requirements into technical endpoints for R&D team
• Original thinker – proven ability to develop novel approaches and strategies to address challenging technical questions
• Proven ability to coordinate work across multiple teams to produce data and narratives required for regulatory submissions and to ensure timely delivery of submissions