Senior Manager, Regulatory Strategy

Job Title:Senior Manager, Regulatory Strategy

Location: Azusa, CA

Position Type: Full-time

Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the business, but most importantly QC/Regulatory. As the team expands operations, they seek a highly qualified and experienced Senior Manager, Regulatory Strategy to join the team.

Job Summary:

The Senior Manager, Regulatory Strategy will play a crucial role in ensuring our compliance with regulatory requirements, optimizing our product development processes, and guiding strategic decision-making. Reporting to the VP of QC/Regulatory Affairs, this position requires a candidate with strong leadership skills, a deep understanding of regulatory frameworks, and the ability to collaborate cross-functionally to achieve regulatory compliance objectives.

Key Responsibilities:

1. Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with the company's business goals. Stay up-to-date with industry regulations and trends to anticipate potential impacts on the organization.
2. Product Compliance: Lead efforts to ensure that all products meet regulatory standards and requirements, including submissions, approvals, and post-market surveillance activities.
3. Cross-functional Collaboration: Collaborate with cross-functional teams, including R&D, Quality Assurance, Legal, and Marketing, to integrate regulatory considerations into product development and commercialization processes.
4. Regulatory Submissions: Prepare and submit regulatory documents, including 510(k)s, PMAs, INDs, NDAs, and international submissions as needed. Maintain communication with regulatory authorities to facilitate approvals.
5. Risk Assessment: Conduct risk assessments to identify potential regulatory issues and develop mitigation strategies. Provide guidance on risk management throughout the product lifecycle.
6. Regulatory Intelligence: Monitor changes in regulatory requirements, industry guidelines, and competitive landscapes to provide insights and recommendations for proactive compliance measures.
7. Team Leadership: Manage and mentor a team of regulatory professionals, fostering a collaborative and growth-oriented work environment.
8. Audit Preparation: Prepare the organization for regulatory audits and inspections, ensuring all documentation and processes meet regulatory standards.
9. Compliance Reporting: Generate reports and metrics to track regulatory compliance and provide regular updates to senior leadership.

Qualifications:

• Minimum of bachelor’s degree in Chemistry or other science disciplines
• 10-12 years of experience in regulatory affairs preferably in a cosmetic or personal care products company; additional experience in quality control is a plus
• 5-7 years of related supervisory/management experience to include building and developing teams
• Must have 5-7 years’ experience as an active participant with cosmetic-centric FDA audits
• Must be a practitioner of and have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada
• Familiarity with notification streams including US & Canada OTC’s, Health Canada CNF, and EU CPNP is beneficial

Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive benefits package, including health, dental, and retirement plans.
• Professional development opportunities.
• Dynamic and inclusive work environment.
• Opportunity to make a significant impact on the success of the organization.

Salary: $95-125k

Location: this position is an onsite role in the Greater Los Angeles area.