Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Quality & Regulatory Manager ensuring product quality and regulatory compliance in CPG. Collaborating with cross-functional teams to drive continuous improvement and support product innovation.
Responsibilities
- Develop, implement, and maintain quality systems aligned with industry standards (e.g., ISO, GMP, HACCP).
- Lead internal and supplier audits, manage CAPAs, and ensure timely resolution of quality issues.
- Monitor product quality metrics and drive root cause analysis and continuous improvement.
- Collaborate with manufacturing and operations teams to ensure quality is embedded in production processes.
- Maintain and improve document control systems and SOPs.
- Ensure compliance with FDA, EPA, FTC, and other relevant regulatory bodies for all product categories.
- Manage product registrations, certifications, and regulatory documentation for domestic and international markets.
- Review and approve product labels, claims, and marketing materials for regulatory accuracy.
- Monitor regulatory changes and communicate implications to internal stakeholders.
- Coordinate with legal and external consultants for regulatory submissions and audits.
- Lead cross-functional projects related to product launches, quality improvements, and regulatory initiatives.
- Develop and manage project plans, timelines, budgets, and resource allocations.
- Track project progress, identify risks, and implement mitigation strategies.
- Facilitate communication and alignment between Operations, Marketing, and Supply Chain teams.
- Partner with Product Development, Marketing, Creative and teams during product development to ensure quality and regulatory considerations are integrated early.
- Review product formulations and packaging for compliance and quality standards.
- Support pilot runs and scale-up activities with quality oversight.
- Provide guidance on regulatory pathways for new product categories or markets.
Requirements
- Bachelor’s degree in a scientific discipline.
- 5+ years of experience in quality, regulatory, or compliance roles within the CPG industry.
- Experience supporting product development and commercialization processes.
- Strong knowledge of FDA, EPA, and other regulatory frameworks.
- Project Management.
- Excellent communication, leadership, and problem-solving skills.
- Proficiency in quality systems, document control, and project management tools.
Benefits
- health insurance
- retirement plans
- paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Corporate Compliance Clerk supporting Business Law team in London, Ontario, maintaining minute books and preparing corporate documentation. Requires 3+ years' experience and offers a hybrid work arrangement.
Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Senior Consultant managing Compliance projects in the medical devices sector with a focus on Quality & Regulatory. Collaborating with a dynamic team in a leading GMP - expert company.
Senior Project Engineer focusing on GMP Compliance in the Life Sciences sector. Responsible for project planning, execution, and client communication in Mannheim, Germany.
Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
Regulatory CMC Manager supporting multi - product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Manage Vodafone's satellite communications policy and regulations while collaborating with teams. Engage in strategic initiatives and develop regulations to support satellite ambitions.
Compliance Analyst managing fraud prevention strategies and governance in Brazil's iGaming sector. Ensuring compliance with regulations and internal policies in a dynamic environment.