Director, Regulatory Affairs
Position: Director, Regulatory Affairs
Location: Aliso Viejo
Posted: February 1, 2021
The Director of Regulatory Affairs will lead the regulatory support team that intersects with the formulation, commercialization and educational activities developed to support the maintenance and launch of new products across the North American business of Metagenics. This position is responsible for the strategic leadership of professional staff who are responsible for the hands-on regulatory activities associated with bringing new Nutritional and Dietary Supplement products to market and commercial product maintenance for a variety of domestic and/or international regulated products. Product categories currently include Dietary Supplements and Medical Foods. The individual is responsible for aligning the strategic direction of the Regulatory Affairs department with the overall Metagenics business strategy. This leader must persuade, influence and inspire through both verbal and written communication as well as demonstrate strong leadership and collaboration skills with their many internal and external partners.
What you'll do:
As the Director of Regulatory Affairs you 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.
- Support the integration of Regulatory strategies supporting NAM (US, Canada, Mexico) and International Expansion markets into Agile squads.
- Support organizational change by translating the company’s strategy, objectives and initiatives into relatable and executable actions by the regulatory staff.
- Support and/or Lead the implementation of processes and tools that enable automatation and digitization of labels and other associated collateral.
- Lead the Regulatory Affairs staff and provide training and mentoring of employees for personal and professional development, ensure that the team is well equipped to provide clear and consistent guidance on the development of claims, labelling and marketing materials, and to effectively and efficiently manage the planning and execution of regulatory filings (on schedule and within budget) as needed.
- Partner effectively with Marketing & Education, Nutrition Science, Product Development, and QA/QC to ensure alignment of regulatory objectives with overall company objectives for the full product development lifecycle.
- Work directly with FDA, trade associations and outside regulatory and legal experts to influence emerging legislation, regulations, guidances and FDA decision making on matters material to Metagenics
- Manage any product recalls and market withdrawals, if necessary
- Ensure appropriate representation of the Company with various trade associations, e.g., AHPA, UNPA, NMFC, etc.
- Work closely with the North American leadership team to develop innovation strategies and business plans that create competitive advantage, are aligned with the Company’s mission and meet or exceed our financial goals.
- Identify and employ advanced regulatory strategies to support marketing and communication with health care professionals
- Support and lead a continuous improvement environment rooted in Agile Leadership principles and Agile methodologies as well as Lean Startup principles
- Provide oversight for RA processes and systems.
- Hire, train and evaluate performance of direct reports.
- Provide strategic regulatory guidance for business development opportunities and in developing growth strategies to enter new business segments, product categories, technology and acquisitions.
- Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch.
You'll love this job if you're:
- 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 10-15 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
- Large scale implementation of digital tools and workflow optimization
- Growth mindset
- Change agility
- Excellent communication skills
- Excellent interpersonal and facilitation skills
- Excellent organizational skills
- Ability to work independently
- Reliable and trustworthy
- Committed to a healthy lifestyle
- Project management capability
Physical requirements/working conditions:
- Sits at a computer station, meeting table or work desk for more than two-thirds of each day
- Stands and walks to other stations and departments throughout the day
- Uses hands and fingers to operate computers and office equipment most of the day
- May stoop or crouch to access files or storage
- Hearing and speech within normal ranges and sufficient for clear communication face to face and especially via the telephone
- Exposed to noise levels typical of office environments
Mental and reasoning requirements:
- Uses critical thinking skills to work with documents and spreadsheets and interpret information furnished in written, oral, diagram, or schedule form. Able to review quantitative and qualitative work and identify questionable items
- Able to set goals based on available information and to plan work in order to meet deadlines
- Able to formulate appropriate responses to requests for data, services and information from internal or external customers with a wide range of personalities and demeanors
- Able to project likely future occurrences based on current or historical data
- Able to work independently and react quickly to changing priorities with a consistent sense of urgency
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.