Regulatory Affairs Manager - Consumer Healthcare
This position will be assigned to manage registrations of OTC drug products, dietary supplements, provide review of finished product labels, review copy and promotional materials, prepare and submit regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.
Responsibilities
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Implement submissions of: OTC drug submissions, supplements/ foods/nutritionals, extracts/raw materials and cosmetics.
- Manage labeling, claims, artwork and promotional material approval plan to assure that they are in conformance with applicable regulatory guidelines and met the highest quality standards.
- Maintain regulatory files and data systems in compliance with related work instructions and regulations.
- Interface with project team members to obtain documentation and establish project’s timelines.
- Work with FDA, vendors and manufacturers. Communicate and cultivate strong relationships with all internal functions across the business, Key Opinion Leaders, External Vendors and Health Authorities.
- Remain current on regulation updates and the OTC and supplements product competitive landscape.
Requirements
- Bachelor’s degree in life science or health related field.
- Minimum of two (2) years direct experience with regulatory submissions.
- Proven experience of developing and implementing regulatory plans; promotion and labeling requirements; commercialization and operations.
- In-depth knowledge and understanding of FDA guidelines and federal regulations.
- Analytical skills with the ability to interpret information and its practical application.
- Strong project management skills, ability to multi-task and meet deadlines.
Job location
New Jersey, Basking Ridge
Employment Type
Part time position, flexible hours APPLY