Passionate about global nutrition? Ready to provide parents with more options to feed their babies? Worried about the effects on our climate due to animal agriculture? Ready to apply your technical skills to create positive change in the world?
We are looking for a regulatory expert to join our team in Durham, North Carolina!
You are a technical leader
- Your diverse understanding of regulatory functions makes you our go-to for reviewing protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
- You can perform critical analyses and interpret data for actionable decision-making that impacts the greater company
- As a life-long learner, you monitor the regulatory landscape and communicate to senior leadership any impacts of guidelines and policies changes on company pipeline strategy
- You thrive in a fast-paced dynamic environment where an eye for detail is essential
- You’re a wizard at synthesizing technical materials and preparing clear and concise written documents and presentations
You are a cross-functional powerhouse
- You’re comfortable working hand in hand with CSO & CEO to develop written and visual materials for regulatory agencies, investor updates, and publishable works
- You can align deliverables between our external regulatory team and internal team
- Your innate ability to articulate complex topics to a scientific audience as well as your business and legal team keeps everyone in-the-know
- You are able to plan and execute direct engagement strategy with regulatory authorities for product specific and policy-issues
- You can assess the alignment of scientific strategy and regulatory strategy
- You have a wealth of contacts throughout regulatory agencies to leverage informally for feedback and advice
You love tackling challenging problems with a team
- You believe in our mission of working towards better infant nutrition, women's health, and sustainability.
- As a conscientious teammate, you're curious to learn from co-workers and share your personal passions.
- You enjoy working collaboratively with a broad and diverse team and stepping outside of your comfort zone
- You're naturally inclined to think critically and creatively to work through murky problems.
- Ambiguity is your jam and you're able to strive ahead without direction
- You hold yourself and others to the utmost ethical standards in all scientific and professional endeavors
- You’re entrepreneurial, innovative, energetic, hands-on, team oriented, and consumer focused, with the ability to think strategically as well as execute project details
- You love mentoring more junior team members on regulatory and policy and managing the growth of a team
Qualifications & Preferred Experience
- Bachelors, Master’s Degree, or PhD in public health, infant nutrition, or a related field, or a JD with emphasis on public policy or regulatory law
- 5+ years regulatory experience, preferably working directly with the FDA and experience with clinical research, regulatory affairs, and agency relationship management
- Must be willing to relocate to Raleigh-Durham, NC within 1 calendar year
- Experience collaborating with regulatory agencies, including FDA
- Strong project management skills and ability to keep projects moving forward
- Ability to understand and communicate regulatory requirements for different areas and countries and associated submission pathways
- Familiarity with regulatory documents, general contents, organization and the methods of filing and tracking
- Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships
- In-depth understanding of the food product development, product commercialization and life cycle management processes
- Experience or exposure to Quality Assurance, Product Development, Clinical Research, and Compliance is desired
- Experience working with Regulating bodies outside of the United States
- Experience leading and managing a team of 3-4