A Fortune 500 company is looking for an experienced attorney for a full-time regulatory and compliance focused role. Candidates must be able to work on-site in Manhattan.
Must have a JD from a top law school
Must be actively barred and in good standing with NY, CA, or DC
10+ years of regulatory, compliance, and administrative legal experience at AM Law 200 firm and/or Fortune 1000 company
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
Experience working with multinational companies and experience with international regulatory compliance required
Experience within recognizable cosmetics, fashion, food, pharmaceutical, biomanufacturing, health, and beauty industries a plus
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 the company’s product development programs and pipelines
Partner with the company’s 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
Excellent writing skills with the ability to translate complex business and legal concepts into clear and compelling text.
Excellent analytical, organizational, research and interpersonal communication skills with attention to detail.
An ability to handle time-sensitive requests and to generate quality work product in a complex matrixed environment.
Exceptional interpersonal skills and the ability to communicate contract requirements to peers and senior stakeholders
Independence and integrity; able to meet deadlines, work efficiently, and manage oneself in a telecommuting/remote environment.
A confident, professional manner that comes across effectively with the company’s lawyers and staff.