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Director, Regulatory Affairs

Company: Metagenics
Location: Aliso Viejo
Posted on: March 22, 2020

Job Description:

SummaryMetagenics is a global lifestyle medicine company, offering products and programs exclusively to health care practitioners. For over 30 years, we have been driven by a scientific concept: How the right nutrition can help people realize their best health possible. We dont compromise on safety, efficacy, or quality - to make sure that we deliver the best results possible. Time after time. Bottle after bottle. We carefully monitor all products to assure purity and safety, from formulation and ingredient selection all the way to the final product. We offer more educational support for health care professionals than anyone else in our field - keeping them in touch with the latest research and nutritional approaches to help manage today's most common illnesses. Metagenics is dedicated to helping people live a happier, healthier life by realizing their genetic potential.--ResponsibilitiesPosition Overview:--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 youll 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 MetagenicsManage any product recalls and market withdrawals, if necessaryEnsure 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 professionalsSupport and lead a continuous improvement environment rooted in Agile Leadership principles and Agile methodologies as well as Lean Startup principlesProvide 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.Youll love this job if youre:--A strong communicator and collaborator and work effectively with all members of the organization, from individual contributors to top execsHighly analytical and strategic. Your problem solving skills are unparalleledYou always maintain a friendly disposition - even (and especially) under pressureQuick on your feet!-- When problems arise, you reliably produce responses and solutionsA facilitator of team successWhat youll need:Experience / Training / EducationBachelor's degree in life sciences; M.S. or Ph.D. a plusCertification from the Regulatory Affairs Professional Society is preferredMinimum of 10-15 years in Regulatory Affairs at a global life sciences companyExperience in direct interaction with the FDAExperience with clinical trials, INDs, NDIs, IRBs and GRAS panelsKnowledge ofComprehensive knowledge of laws and regulations applicable in an FDA-regulated environmentKnowledge of medical nutrition therapyFamiliarity with the medical foods and dietary supplement categories in the U.SKnowledge of Microsoft Office packagesLarge scale implementation of digital tools and workflow optimizationSkills/AbilitiesGrowth mindsetChange agilityExcellent communication skillsExcellent interpersonal and facilitation skillsExcellent organizational skillsAbility to work independentlyPro-activeReliable and trustworthyCommitted to a healthy lifestyleProject management capabilityPhysical requirements/working conditions:Sits at a computer station, meeting table or work desk for more than two-thirds of each dayStands and walks to other stations and departments throughout the dayUses hands and fingers to operate computers and office equipment most of the dayMay stoop or crouch to access files or storageHearing and speech within normal ranges and sufficient for clear communication face to face and especially via the telephoneExposed to noise levels typical of office environmentsMental 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 itemsAble to set goals based on available information and to plan work in order to meet deadlinesAble to formulate appropriate responses to requests for data, services and information from internal or external customers with a wide range of personalities and demeanorsAble to project likely future occurrences based on current or historical dataAble to work independently and react quickly to changing priorities with a consistent sense of urgency

Keywords: Metagenics, Aliso Viejo , Director, Regulatory Affairs, Executive , Aliso Viejo, California

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