Sr. Specialist, Regulatory Affairs

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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

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.

The Role

The Sr. Specialist, Regulatory Affairs will be responsible for supporting and assisting the Regulatory Affairs Manager and/or Head of Regulatory Affairs Regional (whichever is applicable) to coordinate staff to meet the business needs. Primary responsibilities include the approval and review of claims evidence, labels, advertising, regulatory acceptability of ingredients, and critical analysis/strategic solutions to ensure regulatory compliance.

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Key Requirements:

Claims and Substantiation:

• Review and approve proposed claims and evidence are regulatory compliant and scientifically supportable, including evaluation of risk when needed. Additionally, verifies claim substantiation documents are updated and appropriately documented

Labelling and Promotional Material:

• Review and approve product labeling/advertising for compliance to country-specific regulations
• Evaluate regulatory risk for proposed labels/advertising when needed

Ingredient and Formula Evaluations:

• Evaluate regulatory risk for proposed new and updated product ingredients for compliance to country specific regulations
• Review and approve regulatory acceptability of proposed ingredients and/or formulations for NPD

EPD and Change Controls Registrations:

• Review and approve product registration in applicable markets so they are submitted in a timely manner to the appropriate regulatory agencies
• Support Regulatory Affairs colleagues to manage the preparation and processing of all documentation required for product registrations in applicable international markets
• Manage and produce Canadian product applications and registration documents to support new product launches and renovated products

Adverse Events:

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

General Functions:

• Coordinates and manages specific regulatory and operational based projects within the team
• Assist in preparing submissions to consultations, enquiries, reviews conducted by government
• Development of internal Regulatory guidance documents and opinion pieces for cross functional learnings
• Updates internal SOPs / forms / work instructions 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. Accordingly, will provide recommendations for strategic solutions and liaise with appropriate company departments to address issues impacting products.
• Keep abreast of the current and proposed regulations specific to the allocated countries.

Key Competencies:

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

Basic Requirements:

• A bachelor’s degree is required; Tertiary qualifications in one of the following fields of Science -Chemistry, Pharmacy, Food Technology, Nutrition, Naturopathy or Microbiology. Master’s degree, in science related field, is a plus.
• Prior experience operating in a technical environment, knowledge of quality management principles and systems, understanding of manufacturing and packaging in a pharmaceutical environment
• International work experience a plus (Canada, Mexico)
• Experience in food/dietary supplement labeling review and review of related marketing materials
• Minimum 4 years 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

Compensation:

The current range for this role based in Aliso Viejo (Jersey City and Remote-US are additional location options) is $94,566.00/yr. - $139,347.00/yr.

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.

This role may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Health and Wellness:

• Medical, dental, vision
• Annual employer HSA (Health Savings Account) funding for eligible employees who elect an HSA medical plan
• STD, LTD, Basic Life AD&D coverage
• 401k + employer matching
• Vacation and Sick Time
• 2 Volunteer Days off per year
• Emergency evacuation time off
• 11 paid company holidays
• 1 Floating holiday to celebrate your birthday or important religious/holiday to you
• Quarterly product allowance to use towards your favorite Metagenics products!
• Product discount
• Peer to peer recognition programs & more!

A minimum of three workdays per week are to be conducted at the Aliso Viejo Office (25 Enterprise, Aliso Viejo, CA). 

Learn more about how we help patient live happier and healthier lives 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.

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