What You'll Do:
- The Sr. Manager, Regulatory Affairs will be responsible for establishing regulatory strategies and procedures to ensure that all Metagenics products and ingredients, as well as all materials used in marketing, education and sales, comply with the applicable regulations of the FTC, the FDA and the relevant state Departments of Health in the U.S.
- The Sr. Manager Regulatory Affairs will provide strategic/business guidance to the International team responsible for product filings with Health Canada; Cofepris in Mexico; and the regulatory authorities in Metagenics’ distributor markets (e.g., Hong Kong, Japan, Russia, S. Korea, Ukraine, etc.)
- The Sr. Manager, Regulatory Affairs will assure that the planning and execution of each regulatory filing is managed effectively and efficiently, on schedule and within budget. He or she also will lead the Regulatory Affairs staff and provide training and mentoring of employees for personal and professional development.
- The Sr. Manager, Regulatory Affairs will partner effectively with Marketing, Medical Education, Nutrition Science/Therapeutic Platforms, other R&D functions, and QA/QC to ensure alignment of regulatory objectives with overall company objectives for the full product development lifecycle.
- The Sr. Manager, Regulatory Affairs will act as the primary interface with FDA and Health Canada on regulatory issues and submissions. The Sr. Manager, Regulatory Affairs will manage any product recalls and market withdrawals.
- The Sr. Manager, Regulatory Affairs will serve as the principle representative of the Company with various trade associations, e.g., AHPA, UNPA, NMFC, etc.
- This position will report to the Senior Director, Nutrition Science, and will work closely with the R&D leadership to develop strategies and business plans that create competitive advantage, are aligned with the Company’s mission, and meet or exceed our financial goals.
You'll Love This Job If You Are:
- A strong communicator and collaborator and work effectively with all members of the organization, from individual contributors to top execs
- Highly analytical and strategic. Your problem solving skills are unparalleled
- You always maintain a friendly disposition — even (and especially) under pressure
- Quick on your feet! When problems arise, you reliably produce responses and solutions
- A facilitator of team success
What You'll Need:
Experience / Training / Education
- Bachelor’s degree in life sciences; M.S. or Ph.D. a plus
- Certification from the Regulatory Affairs Professional Society is preferred
- Minimum of 8 years in Regulatory Affairs at a global life sciences company
- Experience in direct interaction with the FDA
- Experience with clinical trials, INDs, NDIs, IRBs and GRAS panels
- Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment
- Knowledge of medical nutrition therapy
- Familiarity with the medical foods and dietary supplement categories in the U.S
- Knowledge of Microsoft Office packages
- Excellent communication skills
- Excellent interpersonal and facilitation skills
- Excellent organizational skills
- Ability to work independently
- Reliable and trustworthy
- Committed to a healthy lifestyle
Metagenics, and its companies are committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status with respect to recruitment, hiring, promotion and other terms and conditions of employment. Metagenics takes affirmative action in support of this policy to employ and advance in employment individuals who are minorities, women, disabled, and veterans.