Website Helaina
Helaina is a team brought together by the belief that health and developmental outcomes of all infants can be improved through nutritional options closest to breast milk. Our team is revolutionizing the infant nutrition space by developing a food product meant to uniquely support babies in their earliest stages. Helaina’s R&D ecosystem harnesses the power of naturally occurring biological processes in tandem with modern advances in the space of synthetic biology, fermentation, and improved industrial processing.
We are a fast-paced startup looking for our next team member who is intensely passionate about advancing synthetic biology for food and beverage products and redefining the future of nutrition.
Helaina is looking for a Regulatory Project Manager to support the planning and execution of regulatory initiatives related to GRAS approval as well as pre-clinical study projects. In this position you will manage the day-to-day execution of tasks that advance Helaina’s regulatory strategy. We will look for you to translate strategies into meaningful, executable submission plans, applying your project management expertise to assist us in driving our regulatory initiatives to successful completion.
What You’ll Do
- Partner with the CEO to project manage all regulatory operations, including the coordination, prioritization, and tracking of regulatory activities and submissions associated with the company’s development activities
- Develop and maintain project plans for GRAS and preclinical regulatory activities, tracking submission milestones and coordinating with cross-functional regulatory activities to ensure overall adherence to program timelines
- Develop contingency plans and risk mitigation strategies with input from various functions, resolving issues and mitigating potential delays if they arise
- Organize all relevant documentation, including assets, deliverables, and invoices from vendors/partners
- Serve as the main point of contact for all relevant internal and external stakeholders (clinical study partners, vendors, other third parties)
- Facilitate team meetings, including scheduling, preparation, distribution, documentation, and follow-up
- Support the development, implementation, and continuous improvement of Helaina’s regulatory processes, tools, templates, dashboards, analytics, and project management practices
- Adapt to changing duties based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical, or commercial)
Qualifications
- Bachelor’s or Master’s degree in a related field with a minimum of 4-6 years’ experience in regulatory project management, food, or foodtech
- Working knowledge of fermentation-enabled food product development, FDA regulations (CFR21), guidelines, and submission requirements for GRAS
- Exceptional project management and organizational skills with demonstrated ability to prioritize and manage multiple projects with tight timelines in a dynamic environment
- Ability to think critically with demonstrated troubleshooting and problem-solving skills
- Excellent collaborator with internal and external stakeholders – leadership experience with meetings is required
- Effective communicator who speaks, listens, and write in a clear and concise manner
- Skilled at developing new and unique ways to improve and streamline processes
- Comfort working in a rapidly growing and evolving organization
- Strong support for Helaina’s mission
Bonus Points
- Startup experience
- Experience in infant nutrition
The Logistics
- Terms of employment: Full-time, non-exempt
- Location: NYC or Remote; United States
- Benefits: Full medical coverage, full dental and vision coverage, 401(k) plan, unlimited vacation, supportive parental leave policy, the opportunity for advancement, respectful managers, and supportive colleagues.
- This is a U.S.-based position: In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Helaina is an Equal Opportunity Employer
For more information, please contact careers@myhelaina.com
