Lead Regulatory Affairs Manager
2 weeks ago
Location: Azusa, CA
Position Type: Full-time
We are excited to present a remarkable opportunity within a forward-thinking Cosmetics organization dedicated to excellence and ongoing enhancement across all business facets, particularly in Quality Control and Regulatory Affairs. As the organization expands its operations, we are in search of a highly skilled and experienced Senior Manager, Regulatory Strategy to contribute to our mission.
Position Overview:
The Senior Manager, Regulatory Strategy will be instrumental in ensuring adherence to regulatory standards, refining product development methodologies, and steering strategic decision-making processes. Reporting directly to the VP of Quality Control and Regulatory Affairs, this role demands a candidate with exceptional leadership capabilities, a profound comprehension of regulatory frameworks, and the aptitude to work collaboratively across various departments to fulfill compliance objectives.
Core Responsibilities:
- Regulatory Strategy Formulation: Design and execute comprehensive regulatory strategies that align with the company's overarching business objectives. Remain informed about industry regulations and trends to foresee potential implications for the organization.
- Product Compliance Oversight: Spearhead initiatives to guarantee that all products conform to regulatory standards and requirements, encompassing submissions, approvals, and post-market surveillance activities.
- Cross-Departmental Collaboration: Work alongside cross-functional teams, including Research & Development, Quality Assurance, Legal, and Marketing, to weave regulatory considerations into product development and commercialization efforts.
- Regulatory Documentation: Prepare and submit essential regulatory documents, including 510(k)s, PMAs, INDs, NDAs, and international submissions as necessary. Maintain open lines of communication with regulatory bodies to facilitate approvals.
- Risk Management: Conduct thorough risk assessments to identify potential regulatory challenges and devise mitigation strategies. Provide expert guidance on risk management throughout the product lifecycle.
- Regulatory Monitoring: Keep abreast of changes in regulatory requirements, industry guidelines, and competitive landscapes to offer insights and recommendations for proactive compliance measures.
- Team Development: Lead and mentor a team of regulatory professionals, fostering a collaborative and growth-oriented work culture.
- Audit Readiness: Prepare the organization for regulatory audits and inspections, ensuring all documentation and processes comply with regulatory standards.
- Compliance Metrics: Generate reports and metrics to monitor regulatory compliance and provide regular updates to senior management.
- A minimum of a bachelor's degree in Chemistry or related scientific disciplines.
- 10-12 years of experience in regulatory affairs, preferably within the cosmetics or personal care products sector; additional experience in quality control is advantageous.
- 5-7 years of supervisory or management experience, including team building and development.
- Must possess 5-7 years of active participation in cosmetic-centric FDA audits.
- In-depth understanding of regulations pertaining to 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 such as US & Canada OTC's, Health Canada CNF, and EU CPNP is beneficial.
- Competitive salary along with performance-based bonuses.
- Comprehensive benefits package, including health, dental, and retirement plans.
- Opportunities for professional development.
- A dynamic and inclusive work environment.
- The chance to significantly impact the organization's success.
Location: This position is an onsite role in the Greater Los Angeles area.
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