Manager - Regulatory and Scientific Affairs

February 22

🗽 New York – Remote

Although this job is listed in New York, this company may be open to hiring remote in other states.

💵 $85k - $115k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Helaina

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Helaina is a biotech company pushing the boundaries of what food can do for health.

11 - 50 employees

💰 $20M Series A on 2021-11

📋 Description

• Helaina is a VC-backed biotech startup creating a new category of functional food products. • The Nutrition Scientist will support development and delivery on the nutrition science and regulatory strategies that support the business, including ingredient innovation strategy, brand support, Clinical Program, external engagement and technical support on nutrition related questions from the FDA. • Support regulatory submissions in various markets globally • Design and write clinical trial protocols, clinical study reports and clinical sections of regulatory documents. • Support clinical and preclinical safety study design as well as efficacy study design • Analyze and interpret data from the literature to develop marketing claims and other scientifically substantiated communications/marketing materials. • Communicate with regulatory authorities on topics related to novel ingredient, infant formulas and dietary supplements • Lead research communication strategy for external and internal audiences in collaboration with business leaders • Stay up to date on emerging science and policy issues in the nutrition and health environment and identify nutrition-related research opportunities for business growth • Horizon scan the nutrition space to help develop strategic plans and inform future ingredients, formulations and claims. • Support preclinical, translational and applied research to identify innovative technologies that offer new nutritional/functional products • Developing a network of scientific advisors and consultants; interfacing with key opinion leaders and scientific advisory boards • Ensure technical support is available to key stakeholders of the business, including sales, marketing, regulatory, immunology • Ensure adequate support and subject matter expertise is available to Regulatory for regulatory meetings and submissions • Actively participate on project teams and provide technical input on new ingredient innovation by leveraging the scientific literature.

🎯 Requirements

• You have a PhD in Nutrition or a related field, and 3-5 years of clinical nutrition and/or medical nutrition and/or functional food industry experience. • You have a strong knowledge and understanding of bioactive proteins in human milk. • You have previous clinical research experience including research design and evaluating new technologies. • You have a track record of leading initiatives and informing business leaders of nutrition science priorities. • Being a thought leader and informing strategic projects of the organization • You have experience designing and managing research projects, preclinical and clinical study design, execution, and understanding of statistical analysis in a business setting. • You have a strong foundation in the food/food ingredients industry with experience and/or knowledge of the regulatory environment. • You have excellent problem-solving skills and ability to manage and prioritize multiple projects with complex scientific information requiring high attention to detail and intense deadlines. • Bonus points if you have experience translating DRIs into proposed product formulations for a given population. • RD certification and experience with Clinical Dietitian, US Regulatory, infant nutrition, clinical nutrition and/or medical nutrition and/or functional food industry is a plus.

🏖️ Benefits

• Full medical, vision and dental coverage • Short and long term disability insurance coverage • 401k match (up to 3%) • Unlimited vacation days, including an all-company holiday between Christmas and New Year • Paid Parental Leave for both parents + flexible return to work program • Childcare reimbursement program • Commuter Benefits