What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist position at ZO SKIN HEALTH INC?
Job Details
Description
Summary: The purpose of the Sr. Regulatory Specialist position is to assess products, product changes and formulations for reportability to appropriate regulatory agencies. Primary responsibilities include supporting the department with the approval and review of claims evidence, labels, advertising, regulatory acceptability of ingredients, and critical analysis/strategic solutions to ensure regulatory compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. As part of the Quality Assurance/ Regulatory Affairs team, they will utilize their knowledge of their respective agencies to bring the best solutions to ZO Skin Health’s consumers.
Essential Duties and Responsibilities:
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Performs regulatory assessments of formulations and labeling for various regions including but not limited to Canada, EU, ASEAN, Japan and for various product types including cosmetics and OTC drugs.
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Reviews chemical ingredients and determines the warning labels for each product.
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Reviews claims for marketing collateral and website content and determines acceptability.
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Assists in monitoring regulations and standards for changes and assesses impact.
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Communicates significant issues or developments identified during regulatory activities and provides recommended process improvements to management.
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Coordinates and compiles Regulatory documents that are intended to be submitted to FDA and other Regulatory Agencies as required including international registration documents for cosmetic and drug products.
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Evaluates proposed product formula modifications for global regulatory impact.
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Liaises with international distributors and partners plus internal departments to request, coordinate and provide regulatory information.
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Maintains documentation and related systems necessary for efficient operation of the department.
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Provides advice and support to junior staff.
Other Duties and Responsibilities:
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Maintain a clean work environment
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May assist with vendor, customer and item set up.
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May perform other duties as needed in order to assist with ZO Skin Health operations.
Work Environment: The work environment is indoors in a professional office environment. The floor surfaces are carpeted in office areas and conference rooms with vinyl floor covering typical in hallways, break rooms and computer rooms. Occasionally, they may work in a warehouse environment, as part of a project.
Work Hours: The work schedule is 5 days per week, 8 hours per day. Initial start time may vary, with work hours typically from 8am-5pm. Work hours and shifts are subject to change depending on operating business conditions and needs. The position resides in Orange County but is hybrid with 2 days being remote work.
Physical and Mental Demands: Sedentary, exerting up to 10 pounds of force occasionally, or negligible amounts of force frequently, to move objects. This job also requires constant sitting. Constant use of the upper extremities is required to reach, handle, and position tools and equipment. The employee must know and follow proper safety protocols and maintain a professional and polished appearance. They must be able to efficiently use Microsoft Office Programs and company information systems to retrieve information, generate documents, organize project plans/schedules and coordinate meetings. The employee must also be able to maintain and preserve confidentiality of company information, exhibit strong interpersonal skills and the ability to build relationships with internal stakeholders, including international affiliates.
Supervisory Responsibilities: None
Qualifications
A Bachelor’s degree in a related science discipline is required. Minimum seven (7) years working in a pharmaceutical, CPG, or health/cosmetics industry preferred. The employee must be proficient in Microsoft Office (Excel, Word, Outlook and Power Point). The employee must be highly proficient in written and verbal communication in English as well as have strong technical writing and editing skills. They also must possess excellent analytical skills to read, interpret and summarize scientific material, regulations, guidelines and medical information. The employee needs to possess thorough research skills and strong working knowledge of scientific guidelines and terminologies.
Salary : $100,000 - $115,000
