THE ROLE
The Associate Manager, Registration & Regulatory Compliance will participate, support and in some instances lead assigned regulatory activities for the Lifestyle Brands (LSB) Business Unit located in San Francisco, CA. The successful candidate, based in San Francisco and reporting to the Regulatory Manager, Lifestyle Brands, will provide expert analysis, advice, and expertise in regulatory compliance and registration related issues matters. The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies for all LSB product lines which may include Cosmetics/Personal Care, OTCs, Cleaning Products and Disinfectants. The role requires flawless execution and delivery of end-to-end compliance activities including label and raw material review, process and data management coordination of documentation and submissions to external agencies and governments.
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AREAS OF RESPONSIBILITY
• Identify and interpret applicable laws, regulations and related performance standards that apply to LSB products and their distribution.
• Provide strategic oversight and project management of regulatory submissions to FDA and to Health Canada.
• Understand and apply label requirements for all types of North America sold goods.
• Manage company databases and compliance related IT tools; PLM, Trackwise, etc.
• Provide critical regulatory support to NPD and EPD project teams at all stages from development through product commercialization..
• Author required reports/submissions that are mandated by authorities to ensure uninterrupted business operation.
• Collaborate with colleagues to advance understanding of changes in the regulatory landscape at FDA, Health Canada, FTC, US state legislation, and CEPA amongst others.
• Prepare and submit product notification/registration with relevant authorities in the US and Canada (FDA, EPA, Health Canada, CARB)
• The successful candidate will have a broad-base of regulatory experience, and must be able to provide compliance leadership, mentor staff, and develop and execute strategy.
• Comprehension of and application of relevant GSARA (Global Safety and Regulatory Affairs) processes.
QUALIFICATIONS:
EXPERIENCE:
Bachelor's Degree in a scientific field (biochemistry, biology, chemistry or related scientific field) with direct experience in regulatory compliance in the US and Canada
5+ years of hands-on experience in Regulatory Affairs
Strong knowledge of the current US and Canadian regulations, guidance and policy
Lifestyle Brands (LSB) PERKS: Our values are at the heart of everything we do.
Here are a few of the ways we Care like a Mother for every person against dirty:
• Rockstar health insurance benefits package
• Jollydays: competitive vacation bundle
• Generous retirement match + pre-tax savings options
• 3 Care Days (a.k.a. Volunteer Time-Off) a year, to be a force for good
• Global Ping Pong Tournament + Prom...you heard that right-- let's dance
FURTHER INFORMATION
LOCATION: San Francisco
HOURS: full time, exempt (salaried)
REPORTS TO: Regulatory Manage
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)