Regulatory Affairs Manager

Scope of Position:

The manager is responsible for supporting the Director's goal in both short-term strategies and long-term solutions for Revision Skincare. The manager is responsible for managing several direct reports that will help drive the efforts for our new product development as well as our current marketed portfolio. Furthermore, the manager of RA will provide technical guidance on regulatory compliance and leverage other internal or external experts to drive excellence. This role requires an eagerness to manage young regulatory associates, willingness to collaborate with cross-functional partners, and abides by Revision Skincare's values.

Responsibilities

• Manage a team of regulatory associates responsible for regulatory compliance and provide proper training and project delegation as needed.
• Collaborate with cross-functional partners to provide regulatory and technical guidance for new product launches domestically and internationally.
• Conduct regulatory assessments of new ingredients, formulations, and product changes.
• Review and approve claims, product labeling, marketing materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Oversee regulatory domestic and international submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Create framework and SOP for managing compliance across all facets of the business.
• Fulfill regulatory intelligence and competitive research requests to support new product development.
• Monitor and track changes in regulations and communicate implications to relevant stakeholders.
• Compile Product Information Files (PIF) and ensure the maintenance of all testing reports, ingredient documents, specification sheets, safety data sheets, and applicable certifications.

Skills

• Strong knowledge of state, federal and international personal care, cosmetic and OTC regulations, and guidelines.
• Exceptional attention to detail and ability to review and interpret technical documentation, scientific data, and regulatory guidelines accurately.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to both technical and non-technical stakeholders.
• Strong project management skills and the ability to prioritize and manage multiple projects simultaneously.
• Proficient in using regulatory databases and software applications to track and manage regulatory submissions and documents.
• Strong analytical and problem-solving skills, with the ability to identify and resolve regulatory issues effectively.
• Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels.

Required Qualifications

• Bachelor's degree in a scientific discipline, engineering, or related field. Master's degree is preferred.
• 5-7 years of global regulatory affairs experience in the personal care, cosmetic and OTC industry, with expertise in international regulations and guidelines for product registration and compliance
• 2 -5 years of Management experience preferred
• Proven experience and knowledge of MoCRA, FDA, EU, Canada, and 21 CFR Part 330 regulations.

Leadership Competencies:

• Initiates and drives changes related to marketed products.
• Works cross organizations
• Motivates others and builds trusted relationships.