The FDA Counsel will be responsible for:
- Review packaging and marketing materials (print and digital) to ensure compliance with applicable laws, regulations and guidelines across relevant markets.
- Execute cross-functional review process for packaging and marketing materials that meets company goals and production deadlines, with a view to enhancing efficiency.
- Oversee the operation of the electronic review system, including the tracking of all reviewed and approved materials and periodic reporting to management on the status of such materials.
- Attend review meetings to provide feedback on work in progress, and maintain standards on internal planning, scheduling and documentation for packaging and marketing material reviews.
- Draft and update internal standard operating procedures and other policy documents governing the review of packaging and marketing materials as business needs and regulatory standards evolve.
The FDA Counsel should have the following qualifications:
- A J.D. degree from top accredited law school and admission to the New York State Bar are required.
- A minimum of five years experience as an attorney is required. In-house experience in regulatory law or compliance at a bio-pharmaceutical company (or comparable industry) is strongly preferred.
- An understanding of and experience with FDA (U.S. Food and Drug Administration) and FTC (Federal Trade Commission) requirements for product labeling, advertising, and marketing materials.
- FDA law experience is a plus
- Experience working in a regulated environment such as consumer goods, food & beverage, bio-pharmaceuticals or medical devices.
- An aptitude for a fast-paced environment
- Excellent oral and written communication skills
The firm offers a full benefits package including health, life, dental, and vision along with a great 401K plan, equity packages and more. They genuinely value you as an employee and offer flexible working hours, paid holidays and time off. If you are interested in becoming a part of something truly inspiring, this is an opportunity that you should hear more about.