Regulatory Affairs Manager
Amika
- New York City, NY
- $118,000-140,000 per year
- Permanent
- Full-time
- Assist the Director Regulatory & Compliance with development and execution of regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
- Plan and develop clinical and consumer testing and interpret data for claims support, as well as take part in marketing activities for packaging or advertising approvals.
- Stay updated on changes in regulatory requirements and translate them into actionable steps for the brand.
- Collaborate with cross-functional teams including Product Development, Marketing, Operations, Quality and Sales to ensure that all regulatory requirements are met throughout the product lifecycle.
- Ensure all technical Product Information Files (PIF's) are complete, accurate and up to date.
- Ensure all brand certifications (i.e. Leaping Bunny, Vegan, etc.) are complete, accurate and up to date.
- Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
- Conduct risk assessments and co-develop mitigation strategies to manage regulatory risks.
- Regulatory reviews of raw materials and product formulations, including evaluating chemicals for safety, efficacy and regulatory compliance with U.S. and international regulations.
- Review and approve raw material/alternate sourcing qualifications.
- Review GHS compliance status for safety data sheets
- Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
- Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
- Monitor and track regulatory compliance metrics and provide regular reports to Director Regulatory & Compliance.
- Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.
- Track, monitor and process Adverse Event Product Complaints.
- Lead impact assessment and internal brand communications regarding new and updated regulations.
- Maintain relationship with vendors and CMs as it pertains to regulatory.
- Assist Director Regulatory & Compliance with any post market field issues / investigations and responses, conducting risk assessments and with SOP creation / implementation
- Professional experience in Chemistry, Chemical Engineering, or related science.
- 5-7 years of Cosmetic Regulatory Affairs experience.
- 2 years of demonstrated people-management experience.
- Strong computer skills (PowerPoint and MS Excel).
- Bachelor's degree in a scientific discipline, engineering, or related field. Master's degree is preferred.
- Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products.
- In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and other applicable regional regulations.
- Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
- Professional certifications in regulatory affairs are a plus.
- Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.
- Ability to work effectively, both independently and as part of a team, with diverse groups of people at various levels within the organization.
- High energy and high capacity to handle multiple priorities under time-pressure.
- Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the cosmetic / personal care industry.
- Ability to think and execute creative solutions to complex regulatory/quality issues.
- Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels.
- Ability to work to foster a team environment by providing mentorship to junior level staff while being able to prioritize work.
- Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage.
- Exceptional attention to detail and ability to review and interpret applicable regulations, 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