Regulatory Manager - 256644

Medix™; Gilsum (NH); On-site; USD 140,000 - 200,000; Full time

Job summary

Medix is seeking a Lead Regulatory Director to guide regulatory strategy for ingredients, formulations, and technologies across the full innovation cycle. You will anticipate regulatory risks early in development and provide risk-based solutions to enable innovation while maintaining compliance.

You will oversee horizon scanning, supplier and labeling reviews, and cross-functional execution to ensure products on-market and in development stay compliant.

Qualifications

• Lead regulatory strategy for new ingredients and formulations.
• Experience navigating FDA, EPA and industry standards.
• Ability to translate scientific findings into regulatory actions.

Responsibilities

• Lead regulatory strategy for new ingredients, formulations, and technologies across the full development cycle.
• Develop regulatory horizon scanning and remediation strategies with cross-functional execution.
• Oversee end-to-end regulatory compliance for ingredients, formulas, packaging, and finished products under FDA, EPA, and other standards.
• Approve ingredient submissions and engage with regulators as needed.
• Review and approve labels and packaging for regulatory accuracy.
• Design testing strategies to support compliance and claims validation.
• Collaborate with external consultants on regulatory matters and escalate critical concerns.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory compliance

Project management

Documentation & reporting

Tools

Wrike

Job description

• Lead regulatory strategy for new ingredients, formulations, and technologies across the full innovation cycle, anticipating regulatory risks early in development and providing risk-based solutions that enable innovation while maintaining compliance.
• Develop and own the regulatory horizon scanning process by continuously monitoring emerging regulations and evolving industry standards, assessing their impact on the existing product portfolio and active development pipeline, defining remediation strategies, and driving cross-functional execution to ensure all products on-market and in-development maintain compliance.
• Oversee end-to-end regulatory compliance for new and existing ingredients, formulas, packaging, and finished products across applicable standards (FDA, EPA, NOP, NSF/ANSI 305, Leaping Bunny, Fair Trade, and others).
• Approve ingredient submissions and engage with regulatory entities (e.g., QAI) as needed for escalated or complex issues.
• Ensure ingredient and formula integrity through scale-up, tech transfer, and manufacturing transitions.
• Review and approve all product labels and packaging for regulatory accuracy, including ingredient lists, allergen disclosures, claims, and certification marks.
• Design testing strategies with internal and external laboratories to support compliance, safety, and claims validation.
• Collaborate with external consultants on specialized regulatory matters (FDA, EPA, international compliance) and escalate critical concerns to the RDI Director and Quality Director promptly.
• Review and approve RDI Coordinator document development, such as:
• Formula costs and margin estimates
• Allergen calculations
• Supplier technical documents, safety data, sustainability claims, and regulatory certifications for accuracy and audit readiness
• Ingredient sourcing verification; origin, processing methods, transformation levels, and supply-chain transparency
• Supplier substantiation of ingredient-based, innovation-driven, and sustainability-related claims

Project Management

• Collaborate with the Innovation Project Manager to align priorities and develop initiative proposals in response to market and regulatory changes.
• Lead and document RDI actions when Quality requests a collaborative ingredient or product investigation, with support from the RDI Director.
• Develop internal briefs and executive summaries translating scientific findings into accessible language for cross-departmental audiences.
• Own the product storytelling arc from ideation through formulation strategy, claim development, and mechanism of action narratives.
• Translate ingredient research, scientific literature, supplier technical data, and clinical findings gathered by the RDI Coordinator into strategic briefs that evaluate regulatory viability, formulation feasibility, and brand alignment—delivering clear recommendations to support go/no-go decisions across the innovation pipeline.
• Partner with the RDI Director to develop milestone timelines across the product development pipeline using Wrike.
• Create and oversee completion of tasks for the RDI Coordinator, Lab Scientist, and Lab & Scale-Up Technician.
• Attend PM meetings and communicate RDI updates on product development activities.
• Own the end-to-end scale-up documentation pipeline, coordinating inputs from the Lab Cosmetic Scientist and Scale-up Technician to assemble complete handoff packages including MBRs, processing instructions, and risk assessments that meet Quality requirements at each stage gate.
• Lead RDI's technical documentation for tech transfer to contract manufacturers, ensuring formulation specifications, qualification materials, and approval deliverables are complete and aligned with internal quality standards.
• Identify documentation gaps and process risks throughout scale-up and tech transfer, integrating improvements back into the stage development workflow to strengthen readiness for future projects.

Leadership & Team Management

• Provide direction, coaching, and priority-setting for the RDI Coordinator, including employee check-ins and ABC meetings.
• Direct the RDI Coordinator in gathering, organizing, and maintaining supplier documentation, safety data, and technical literature to support ongoing research efforts.
• Establish workflows and best practices for ingredient vetting, regulatory documentation, and compliance tracking.
• Manage the ingredient and regulatory innovation projects cross-functionally, delegating operational tasks while retaining strategic advice.
• Serve as the primary RDI interface for ingredient integrity and regulatory assurance across all departments.
• Back up RDI Director in Leadership and Team management activities.
• Serve as the primary regulatory liaison to the Quality department, providing technical/regulatory assessment for adverse events and supporting certification, specification, and label handoffs.