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Manager, Regulatory & Scientific Affairs
Posted 13 days agoViewed
💎 Seniority level: Manager, 3-5 years
💸 Salary: 100000.0 - 120000.0 USD per year
🔍 Industry: Biotech
🏢 Company: Helaina👥 11-50💰 $45,000,000 Series B 5 months agoPersonal HealthBiotechnologyHealth CareParenting
🗣️ Languages: English
⏳ Experience: 3-5 years
Requirements:
- PhD in Nutrition or a related field, and 3-5 years of clinical nutrition and/or medical nutrition and/or functional food industry experience.
- Strong knowledge and understanding of bioactive proteins in human milk.
- Previous clinical research experience including research design and evaluating new technologies.
- Experience designing and managing research projects, preclinical and clinical study design, execution, and understanding of statistical analysis in a business setting.
- Strong foundation in the food/food ingredients industry with experience and/or knowledge of the regulatory environment.
Responsibilities:
- 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.
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