Senior Manager, Regulatory Strategy

Job Description

Job Description

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 :

• 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 :

Benefits :

Salary : $95-125k

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