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Years of Experience
Date Last Verified
ProfileAssociate Counsel, Regulatory Duties: Provide legal advice and guidance on compliance with regulations related to the manufacturing, development, testing, packaging, labeling, and sale of OTC drugs and cosmetics, as well as support on issues relating to ELC product development programs and pipelines. Partner with ELC business units in the development, implementation, and continued education of the company’s QA and Regulatory compliance policies and procedures. Coordinate and manage outside law firms with respect to government audits/investigations. Liaise with government regulatory bodies and administrative agencies on behalf of the company regarding product issues, inspections, and inquiries. Draft, negotiate, and provide guidance related to supplier quality manufacturing agreements. Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions. Manage paralegals and assistant counsel on legal matters as required.
Qualification and Experience
Qualifications: JD Degree from a top law school. Cosmetic and OTC industry experience required. Licensed to practice; NY, CA, or DC preferred. 10+ years of regulatory, compliance, and administrative legal experience at AM Law 200 firm and/or Fortune 1000 company. Global experience. Role requires a strong understanding of cosmetic and OTC regulations including those related to FDA compliance, GMP requirements, product formulation, packaging, labeling, etc. Experienced business lawyer with ability to form strong relationships with business leaders and serve as a counterpart to the QA and R&D teams. Ability to execute in a complex matrixed environment . Licenses or Certifications: Admission in good standing to a state bar; State of New York, California, or District of Columbia preferred.
Job Number: 173359