Sr. Specialist, Regulatory Affairs

Metagenics, Inc.; Aliso Viejo (CA); Hybrid; USD 94,566 - 139,347; Full time

Benefits offered by this job

401k + employer matching

Vacation and Sick Time

Quarterly product allowance

Product discount

Job summary

Metagenics, Inc. is seeking a Sr. Specialist in Regulatory Affairs in Aliso Viejo, CA. This role requires coordination and support to ensure regulatory compliance through the evaluation of labeling and claims. The ideal candidate has a Bachelor's degree in a science-related field and at least 4 years of experience in the dietary supplement or pharmaceutical industry.

The position offers a salary range of $94,566 - $139,347 annually and includes benefits such as medical, dental, and 401k matching.

Qualifications

• At least 4 years of experience in the dietary supplement, food, or pharmaceutical industry.
• Understanding of claims and ingredient regulations.
• Experience in labeling review and marketing materials.

Responsibilities

• Support the Head of Regulatory Affairs in coordinating staff.
• Review and approve claims for regulatory compliance.
• Evaluate regulatory risks for new ingredients.

Skills

Knowledge of FDA and FTC regulations

Ability to analyze scientific literature

Familiarity with cGMP

Proficiency in Microsoft Office

Education

Bachelor's degree in Science

Master's degree in a related field

Job description

The Sr. Specialist, Regulatory Affairs will be responsible for supporting and assisting the Head of Regulatory Affairs Regional 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.

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

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.
• 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 required.
• 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

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).

Metagenics is committed to Justice, Equity, Diversity, and Inclusion by providing equal employment opportunity without regard to race, color, nationality, ethnicity, religion, sex, gender identity or expression, sexual orientation, age, disability, marital status, veteran status, or any other legally protected status with respect to recruitment, hiring, promotion and other terms and conditions of employment. We believe that diverse perspectives strengthen our work and innovation.