What you'll do:

Claims and Substantiation

• Under the direction of and in conjunction with the Manager, Regulatory Affairs, coordinates and collaborates with marketing brand managers and research and innovation (R&I) leads, in order to develop regulatory compliant and scientifically supportable claims. Additionally, ensures claim substantiation documents are updated and appropriately documented.

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.

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.

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.
• Produce 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

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

General Functions

• Updates Regulatory Affairs database, allowing other cross functional groups access to information, to include:

• Approved claims
• Regulatory status of raw materials
• Country-specific projects
• In-process and approved substantiation files, and more
• Development of internal Regulatory guidance documents and opinion pieces for cross functional learnings.
• Updates internal SOPs / forms and assist with internal training of associates Intradepartmental with Regulatory and internal processes.

• 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.
• Keep abreast of the current and proposed regulations specific to the allocated countries.

What you'll need:

• 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)
• 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 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.)

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 to 10 pounds regularly; lifts 25 pounds occasionally
• Exposed to noise levels typical of office environments

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.