Regulatory Ops – Specialist, Sr. Specialist, Manager, Sr. Manager
Several full-time salaried positions are now open in our Regulatory Operations team, within the Marketing Review Services (MRS) department at REJIMUS, INC., a preeminent regulatory management consulting firm to the Food & Beverage, Dietary Supplement, Animal Feed, Cosmetic and Homeopathic industries. Final job title and compensation plan as a key regulatory personnel member depend on the experience, applicable skillset(s) and how well the interviewee does during the course of the interviews with the team here at REJIMUS and on the written assessment. We seek to gauge your regulatory knowledge, writing ability, approach to evaluation of compliance, and more through real-life scenario applications that we face with our clients. In the MRS department, you will be responsible for providing regulatory review expertise and execution of tasks or projects in accordance with a multitude of regulations including but not limited to project/task ownership, marketing development support for clients, labeling and marketing reviews, claim substantiation, claims reviews/development, accreditation/certification support, labeling design/development support, scientific research, regulatory due diligence, formulation reviews, quality documentation review/development, and support for report drafting and reviews of reports and any other regulated marketing copy. You will organize regulatory information, track and control documentation, develop and management team/service specific documentation controls, proof-read and provide other strategic compliance input on works in accordance with daily operating practices of REJIMUS and the regulations as cited under the applicable regulations relevant to the task(s)/project(s) assigned.
- Lead by example in the the team that includes a continued awareness, understanding and pro-active response to FDA regulations, guidance documents, and enforcement actions. Implement standards for and oversee technical review and organization of documentation to meet USDA, FDA and FTC requirements for the marketing of client products (including dietary supplements, foods, beverages, personal care products and cosmetics)
- Perform reviews for product labeling and label claims to ensure the applicable regulatory requirements are met
- Assess claims for the allowance and compliance, providing corrective language where/when feasible based on sound regulatory experience, interpretations and training
- Provide formula and ingredient evaluations
- Oversee client certifications and registrations for food registrations, labeling, claims and other requests
- Help implement and oversee systems for the preparation of substantiation documents to support product label and advertising claims
- Work directly with cross-functional teams, including product development, marketing, counsel, regulatory consultants and government agencies in order to register the company’s products and comply with applicable regulations and laws
- Ensure that all client marketing materials are compliant in relevant markets and channels and maintain/manage documentation files including for social media sites, websites, channels, etc.
- Coordinate with Project Managers regarding regulatory timelines and risks
- Have a working knowledge of relevant product laws and regulations
- Provide review/input in to raw material and finished product specifications
- Exhibit deep expertise with, e.g., 21 CRF Part 101, 21 CFR Part 111, and 21 CFR Part 117 for all appropriate systems they support, as well as critical documentation.
- Manage required product testing including but not limited to Prop 65 compliance, certifications and specifications as requested by clients for their products
- Operate seamlessly with team in a project management driven environment to keep all tasks updated/current, reporting of billable time, and proper utilizing of company softwares and resources to ensure traceability and accountability
- BS/BA is required. Preferred scientific field unless experience demonstrates. MS, PharmD, Ph.D., or MD preferred.
- Ideally >7 years experience in a Regulatory Affairs and/or Quality Assurance/Quality Control role within the applicable industries supported by the company with direct applicable experience in industries supported
- Experience with developing regulatory strategy for dietary supplements, foods, and cosmetics, including claims, labeling, and claim substantiation, formulation reviews, certifications, etc.
- Experience with labeling, label reviews, QA or Regulatory Roles prior within the food/supplement sectors
- Extensive proficiency in MSOFFICE, ADOBE, and Mac/Apply systems to complete work products/reviews
Total Target Compensation: $90K-$130K, uncapped. Such is performance based role (with base salary and quarterly/annual bonuses based on achieving monthly billing targets).
100% Paid Benefits for Employees and all Dependent(s):
– Medical Insurance (Gold/Platinum Plans for 2 HMO and 1 PPO options)
– Vision Insurance
– Dental Insurance
Other Benefits available:
– 401(k) Safe Harbor 100% vesting
– Dedicated HR through PEO with Online Employee Portal for all payroll and administrative needs
– 13 Company Paid Holidays per year
– Several other life benefit services and insurance options available e.g. Financial Planning, Counseling Services, etc.
– Corporate employee discounts and perks (online and in-office) e.g. Online Masterclass, Theatre-tickets, Full Office Kitchen with weekly delivery of Fruits/Vegetables/Juicing, Corporate Wine Memberships and more, etc.
If you are interested in applying for this position, please email your resume to: firstname.lastname@example.org