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    Regulatory Affairs Manager - New York, United States - Amika

    Amika
    Amika New York, United States

    4 days ago

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    Description

    hi there, we're amika. a friend to hair, hairstylists, her, him, them, + you. amika means friend in the language esperanto and is a symbol of our belief in the power of community + the beauty of diversity.

    brooklyn-born + salon raised: where creativity + culture is a way of life. we're a collective of creatives, hairstylists, chemists, + product enthusiasts that like to bend the rules.

    we created 11 collections for every hair type, texture + style - all hair is welcome.

    the job:

    as a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with global regulatory requirements and standards in the cosmetic hair care/personal care industry. This position will also ensure the brand adheres to all retailer ingredient policies (i.e. clean lists) as well as internal brand guidelines (i.e. brand profile) and will report directly to the Director Regulatory & Compliance. Responsibilities will include assistance in developing and implementing regulatory strategies, collaborating with cross-functional teams, and ensuring that products and processes meet all relevant regulatory requirements and guidelines. This role requires strong attention to detail, exceptional communication skills, and a deep understanding of global regulatory processes and requirements. As Regulatory Affairs Manager, you will manage the regulatory team, as well as train and motivate the team for improved customer results.

    location: remote (must be based in the US)

    salary: $118,000 - $140,000 + benefits

    what you'll do

    • 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
    must haves:
    • 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
    ready to apply?

    Please click the link that will bring you to our careers page through Greenhouse. Submit a cover letter describing yourself and why you'd be the perfect fit, along with your resume.
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