Sr. Specialist, Regulatory Affairs

Metagenics•Aliso Viejo, CA

2d•$94,566 - $139,347•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

Master’s degree, in science related field, is a plus.
International work experience a plus (Canada, Mexico)

Responsibilities

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
Review and approve product labeling/advertising for compliance to country-specific regulations
Evaluate regulatory risk for proposed labels/advertising when needed
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
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
Support adverse event reporting system and submission of relevant documents, as applicable
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
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.

Benefits

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!