Associate Director, Regulatory Operations

About this job

The UPSIDE Foods Global Scientific & Regulatory Affairs (GSRA) team is hiring an Associate Director, Regulatory Operations to proactively create and build effective regulatory compliance operational capabilities.

In this role, you will combine your knowledge of scientific, regulatory, and business issues to ensure product compliance and meet the required legislation.

Key responsibilities include setting up and driving our global regulatory data standards, regulatory processes & analysis, and applicable systems & platforms for compliance.

Additionally, this role will have corporate-wide influence and is generally considered a key opinion leader and an expert resource both within UPSIDE and externally. Responsibilities Include

• Responsible for overall regulatory knowledge management and creating standardized technical documents including label information documents for commercialization readiness.
• Manage processes involved with regulatory dossier submission file templates (new, amendments and supplements), maintain product filings, registration listings, and other applicable regulatory correspondences.
• Facilitate and work closely within GSRA’s Regulatory Affairs & Scientific Affairs leads on the preparation of technical regulatory documentation for agency submission and coordinating with Regulatory Program Manager.
• Develop, track and report on all key project deliverables including GSRA Metrics & Dashboard Reports for senior management executives and the broader enterprise for visibility.
• Develop regulatory processes including GSRA standard operating procedures, policies, guidelines and / or chassis in compliance with applicable regulatory requirements and drive core training and documentation on regulatory processes, and other applicable regulatory operations requirements to maintain compliance with relevant regulatory agencies.
• Provide technical analysis to Regulatory Affairs and guide the specifications, product optimization and readiness reports, tables and conclusions for submissions and product nutritional, label, and claims compliance.
• Serve as a regulatory thought leader by supporting stage-gating for commercialization, providing regulatory perspective for new and renovated products, identifying and resolving regulatory hurdles efficiently, and assuring application of departmental policies.
• Drive optimization of GSRA systems and platforms for regulatory compliance, and act as SME for software releases, as applicable, including specifications and artwork systems, and end-to-end product lifecycle commercialization process flow.
• Provide support on scanning emerging issues and regulations throughout the product life cycle, and collaborate with Regulatory Affairs to issue timely regulatory change briefings.
• Assure the development of multi-level project planning to achieve short and long-term business objectives utilizing systems efficiencies and productive outputs.

About You

• Bachelor’s degree in a science field and a PhD or MS in a technical or scientific area (e.g. Nutrition Science, Toxicology, Chemistry, Biology, etc).
• Regulatory Affairs Certification (RAC), a Registered Dietitian (RD) license, or M.B.A. is a plus.
• 5+ years experience in a regulated industry (e.g., pharmaceutical, medical products, or food & beverage) with core regulatory experience but may consider quality assurance, research and development / support, scientific affairs, operations, or related area.
• Strong knowledge of FDA & USDA regulatory guidelines, policies, standards, practices, requirements, and precedents. (Knowledge of international regulatory requirements likeEFSA, Health Canada, Singapore Food Agency is a plus).
• Good understanding of FDA & USDA regulatory agency structure, processes, and key personnel.
• Experience providing regulatory support to business partnerships related activities.
• Must be able to juggle multiple and competing priorities and think analytically with good problem-solving skills.
• Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

Who You’ll Work With

While we expect growth in all functions in the next 1-2 years, this role will most frequently interact with our Regulatory Affairs and R&D teams

Compensation Range : $185,000 - $205,000*

• Pay may vary depending on factors including job-related knowledge and skills. UPSIDE Benefits!
• Stock options for all full-time incoming team members!
• 90-100% employer-paid healthcare premiums for team members (medical including HSA and FSA , dental, and vision)
• Pet insurance for your furry family members!
• Unlimited PTO
• DE&I (Diversity, Equity & Inclusion) Council and People Engagement Programs
• Company-sponsored learning & development opportunities

UPSIDE Foods is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Our company-wide mission is to create a product for everyone, so we are deeply committed to having teams and leaders that reflect this mission.