Associate Manager, Regulatory Affairs
Core
North American regulatory subject matter expert for Food Biosciences products, including food enzymes and cultures, ensuring compliance and supporting commercialization.
Role type
Associate Manager, Regulatory Affairs
Builds
Regulatory strategies, submissions (GRAS, Health Canada), and compliance frameworks for food ingredients and biotechnology solutions.
Domain
Food Science / Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, GRAS and Health Canada filing preparation, risk evaluation, stakeholder management, documentation practices, cross-functional collaboration, regulatory intelligence gathering.
Preferred skills
Experience with enzyme/culture/fermentation/biotechnology/dairy portfolios, established relationships with North American regulatory authorities, creative problem-solving in ambiguous regulatory environments.
Technologies
Regulatory frameworks (US/Canada), submission management systems, industry association networks.
Responsibilities
Assess regulatory developments and business impact, lead regulatory submissions and notifications, partner with R&D and Commercial teams on product launches, provide compliance guidance to stakeholders, monitor ongoing product compliance, evaluate regulatory risks, build relationships with authorities and associations.
Seniority
Mid-level Manager, hands-on IC with strategic oversight