Sr. Specialist, Regulatory Affairs

07 Jun, 2021

Jobs

Sr. Specialist, Regulatory Affairs

Metagenics
Aliso Viejo, CA

About Metagenics:

 

Metagenics believes in helping people live happier, healthier lives by realizing their genetic potential. It’s why, when we defined Metagenics’ Mission, Values, and Vision, we started with our company’s own DNA. United by purpose and core values (Integrity, Authenticity, Respect, Diversity & Inclusion and Healthy & Happiness) the Metagenics’ team is dedicated to providing effective nutritional products and solutions, for healthcare professionals.

 

People Culture First:

 

At Metagenics, we believe the way we do business is as important as the business we do; that a company in the nourishment business should nourish its people, too. So, we incorporated healthy, sustainable care into every dimension of our culture. Our diverse and expansive team are a prime example of the power of a people-first approach. We know first-hand, when an organization prioritizes internal growth and fosters empathy, its people come together to set an example of what the world can become.

Responsibilities

Position overview:

 

The Sr. Specialist, Regulatory Affairs will be responsible for providing support to the Regulatory Affairs department. Primary responsibilities include the management of a portfolio of products in areas of development, registration, substantiation and maintenance of product claims, performing critical review and evaluation of new and existing ingredient status and acceptability, regulatory review of associated marketing, promotional and educational materials, and performing reviews of product labeling to ensure regulatory compliance.

 

What you’ll do:

 

Claims and Substantiation

  • Under the direction of and in conjunction with the Sr. Manager, Regulatory Affairs, coordinates and collaborates with marketing brand managers, associate brand managers and Nutrition Science health category leads, in order to develop compliant, science-based claims
  • In collaboration with Nutrition Science, regulatory
  • Critically evaluates the regulatory acceptability of proposed food, dietary supplement, and medical food claims, rationales and substantiation, and proactively suggests allowable alternative claims and/or improved evidence as necessary
  • Working with Regulatory Affairs Department colleagues, ensures the consistent use of claims across all marketing tools (i.e. label copy, web content, marketing collateral etc.)

Labelling and Promotional Material

 

  • Performs thorough review of product labeling to ensure appropriate claim use and compliance with dietary supplement/food labeling regulations in the US, Canada, and international markets
  • Performs thorough review of marketing materials to ensure appropriate and regulatory-compliant messaging; collaborates with marketing to develop revised language as necessary
  • Provides regulatory review of materials created for medical education under the umbrella of Metagenics Institute.

Ingredient and Formula Evaluations

 

  • Ingredients are evaluated based on country-specific regulations for US, Canada, and other international markets in collaboration with in-country distributors/consultants
  • Tracks ingredient evaluations in database as one source for country-specific information
  • Includes determination for foods, dietary supplements, and medical foods for GRAS/non GRAS; Monitor GRAS self-affirmation process and track in regulatory database. Provide, as needed, scientific documents from existing database
  • Tracks NDI notification process and provides scientific documents from existing database
  • Tracks and participates in IND application process, as applicable
  • Tracks new product launches and ensures timely submission of 30-day notices

Registrations

 

  • Working with Regulatory Affairs colleagues, and cross-functional colleagues, to manage the preparation and processing of all documentation required for product registrations in applicable international markets by creating customized technical registration dossiers for conformity to country-specific regulations
  • Create Canadian product applications and registration documents to support new product launches and renovated products

Import

  • Research import requirements for ingredients and product shipments for international markets when needed.

Adverse Events

 

  • Manage adverse event reporting system and submission of relevant documents, as applicable

General Functions

  • Manages and updates Regulatory Affairs database, allowing other cross functional groups easier access to information, to include:
    • Approved claims
    • Regulatory status of raw materials
    • Country-specific projects
    • In-process and approved substantiation files
    • GRAS projects
    • NDI submissions
    • IND applications
    • Registration / Import approvals and expirations (where applicable)
    • Global ingredient database
    • Other additions, as deemed important
  • Development of internal Regulatory guidance documents and opinion pieces for cross functional learnings
  • Interface and/or participate in Agile Development teams as needed to support product launches and renovations and serve as a strategic regulatory partner to the team

Industry Surveillance

 

  • Monitors competitive claims, FDA’s and FTC’s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally.
  • Assist with training regarding claim development, medical food rationale development (particularly for “Distinctive Nutritional Requirements”), claim substantiation, NDI compliance, etc.

You’ll love this job if you’re:

 

  • You enjoy the application of regulatory knowledge to business goals and objectives such that your work supports the overall business needs
  • You are have an agile mindset
  • You have strong project management skills, like to stay organized and are detail oriented
  • 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
  • Steady on your feet!  When problems arise, you reliably produce responses and solutions

What you’ll need:

 

Experience / Training / Education 

  • A bachelor’s degree is required; a bachelor’s degree in a science or engineering related field is strongly preferred. Master’s degree, in science related field, is a plus
  • International work experience a plus (Canada, Mexico, Korea)
  • Experience in food/dietary supplement labeling review and review of related marketing materials
  • Minimum 3 years (4-6 years preferred) of experience in dietary supplement, food and/or pharmaceutical industry, with in-depth knowledge of FDA and FTC regulations, as they relate to claims and ingredient acceptability

Knowledge of

  • Knowledge and understanding of current FDA and FTC claims and labeling regulations, guidance to industry and enforcement discretion. Understanding of current litigation environment, preferred
  • Working knowledge of nutrition, chemistry, biology and statistics
  • Working knowledge of Microsoft Office applications (Word, Excel, PowerPoint, etc.) 

Skills/Abilities 

  • Ability to understand and apply information from complex materials such as product formulas, specification sheets, scientific journals and government regulations
  • Ability to conduct research on scientific and medical topics and to interpret information appropriately.
  • Strong analytical skills
  • Strong facilitation and communication skills both written and oral
  • Strong problem solving skills and strong team player
  • Must be able to represent regulatory interests in an interactive team environment
  • Ability to work independently as well as a member of a project team, be self-motivated, manage high volume of work, prioritize effectively, meet numerous deadlines and repeatedly shift between projects
  • Ability to maintain “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity
  • High degree of flexibility, organization and ability to pay close attention to detail

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
  • Requires clear vision at 20 inches or less with or without corrective lenses
  • Hearing and speech within normal ranges and sufficient for clear communication face to face and especially via the telephone
  • Lifts up to10 pounds regularly; lifts 25 pounds occasionally
  • 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.
  • Expert problem-solving and data-analysis skills
  • 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

Learn more here

 

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.

Job posted: 2021-06-07