Director, Regulatory Affairs & Compliance

Bonafide•New York, NY

10d•$143,000 - $239,000

About The Position

The Director of Regulatory Affairs & Compliance will proactively focus on regulatory compliance of the Company’s finished products sold in the US as well as advise on the regulatory classification for potential products within the Company’s pipeline. The Director of Regulatory Affairs & Compliance will have a strong working knowledge of 21 CFR, including Parts 101, 110, 111, 117, 190, 201, 314, 329, 330, 701, 801, and 814, consult with outside consultants in less knowledgeable regulatory categories, and will identify regulatory gaps and work to close them. He/she will review the company policies and procedures to ensure they comply with federal, state and local regulatory guidelines. The Director of Regulatory Affairs & Compliance will also work closely with Quality, Legal, R&D, Sales, and Marketing departments, and will report to the Corporate General Counsel.

Requirements

Minimum 10 years of experience in Regulatory within the dietary supplement and/or food industry.
Working knowledge of Dietary Supplement Health and Education Act (DSHEA).
Working knowledge of 21 CFR Parts 110, 111, 117, 190, 201, 314, 329, 330, 701, 801, and 814.
Knowledge of current FDA and FTC guidance documents and enforcement policies within the food and dietary supplement industries.
Ability to understand and interpret clinical trial reports, medical journal articles and other medical/scientific materials that support product claims.
Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications.
Demonstrated ability to be proactive, independent, highly motivated, and effective in managing multiple projects, including outside consultants and counsel.
Excellent communication skills with the ability to clearly communicate orally and in writing.
Excellent planning, prioritizing and organizational skills.
Highly proficient with corporate software tools - Microsoft office suite including Word, Excel, PowerPoint.
Bachelor’s degree or higher, preferably in life sciences or related area.

Nice To Haves

Experience managing FDA 510(k) and ANDA submissions a plus.
Experience in working with finished products.

Responsibilities

Review product formulas and raw materials for compliance with applicable regulatory requirements, including ascertaining the regulatory classification of any proposed new products, and help generate new and updated product labels including food/supplement facts panel, ingredient statements and allergen statements ensuring compliance with regulations.
Review and approve label artwork, graphics and text as well as marketing assets and website claims with a high level of detail for accuracy.
Collaborate with multiple functions and support innovation projects and new product development.
Monitor US and global regulatory legislation and provide the team with regular updates.
Assist with the implementation of programs, policies, SOPs and practices to ensure products comply with appropriate regulations.