Director of Regulatory Affairs
Umami Meats
Legal
Bengaluru, Karnataka, India
Posted on Thursday, June 13, 2024
At Umami Bioworks, we are pioneering cultivated, 'not caught' seafood by developing the production system for delicious, nutritious, and affordable cultivated fish, starting with IUCN Red Listed species that are difficult to farm and being driven extinct by human consumption. We are partnering with food producers to scale our cultivated seafood production system to provide people around the world with a stable, resilient, local supply of seafood free from mercury, antibiotics, microplastics, and ocean pollutants.
We’re on a mission to empower humanity to eat sustainably without sacrifice. We believe the only way to change how the majority of the world eats meat and seafood is to create real seafood - the most delicious, healthiest seafood available - without the environmental and animal welfare consequences of our current practices.
We’re a venture-backed biotech startup located in Singapore where some of the world’s smartest, most passionate people are pioneering a sustainable food future that is attractive and accessible to people around the world. We are united by our collective drive to ask tough questions, take on challenging problems, and apply cutting-edge science and engineering to create a better future for humanity. At Umami Bioworks, you will be encouraged to dream big and will have the freedom to create, invent, and do the best, most impactful work of your career.
Umami Bioworks is looking to hire an inquisitive, innovative, and independent Director of Regulatory Affairs to join our R&D team in Bangalore, India.
Role:
We’re on a mission to empower humanity to eat sustainably without sacrifice. We believe the only way to change how the majority of the world eats meat and seafood is to create real seafood - the most delicious, healthiest seafood available - without the environmental and animal welfare consequences of our current practices.
We’re a venture-backed biotech startup located in Singapore where some of the world’s smartest, most passionate people are pioneering a sustainable food future that is attractive and accessible to people around the world. We are united by our collective drive to ask tough questions, take on challenging problems, and apply cutting-edge science and engineering to create a better future for humanity. At Umami Bioworks, you will be encouraged to dream big and will have the freedom to create, invent, and do the best, most impactful work of your career.
Umami Bioworks is looking to hire an inquisitive, innovative, and independent Director of Regulatory Affairs to join our R&D team in Bangalore, India.
Role:
- 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 Umami’s 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.
- 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)
- 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