The RoleThe 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 (considering Remote as an additional location option) 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). #LI-POST
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