Senior Manager, Regulatory Strategy
1 month ago
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:
- 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.
- Product Compliance: Lead efforts to ensure that all products meet regulatory standards and requirements, including submissions, approvals, and post-market surveillance activities.
- 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.
- 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.
- Risk Assessment: Conduct risk assessments to identify potential regulatory issues and develop mitigation strategies. Provide guidance on risk management throughout the product lifecycle.
- Regulatory Intelligence: Monitor changes in regulatory requirements, industry guidelines, and competitive landscapes to provide insights and recommendations for proactive compliance measures.
- Team Leadership: Manage and mentor a team of regulatory professionals, fostering a collaborative and growth-oriented work environment.
- Audit Preparation: Prepare the organization for regulatory audits and inspections, ensuring all documentation and processes meet regulatory standards.
- 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
- 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.
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