QDS – Regulatory Manager​/Regulatory Specialist

Several full-time salaried regulatory positions (based upon applicable experience) are now open in our Regulatory Operations team, within the Quality Development Services (QDS) department at REJIMUS, INC., a preeminent regulatory management consulting firm to the Food & Beverage, Dietary Supplement, Cosmetic and Homeopathic industries. Job title and performance-oriented compensation plan for key regulatory personnel member depend on the experience levels, education, and applicable skillset(s) as well as how well the interviewee does with the REJIMUS team and on the written regulatory exam.

We seek to gauge your regulatory knowledge, writing ability, approach to evaluation of quality and compliance challenges through real-life scenarios that we face with our clients on a daily basis. In the QDS department you will be responsible for task and project ownership, client support in areas of regulatory compliance, including by not limited to manufacturing operations, standard operating procedure writing/optimization, specification writing, auditing, training, product development support, regulatory due diligence, formulation reviews, operational compliance, quality documentation review/development, FSMA/HARPC Plan writing/reviews, etc.

Additional responsibilities will include cGMP Facility Audits, GMP training, safety data sheets, registrations in US markets, support for report drafting and reviews of reports and marketing copy, and aid the design and development of controlled documentation, as well as providing other support to colleagues as your skills permits and as required. You will organize project and regulatory information, track and control documentation, tasks, proof-read and provide input on compliance work in accordance with the practices and standards set forth by REJIMUS, including managing of daily work schedule, team communications, and accountability to all work products submitted and productivity metrics.

• Write, review, collect, coordinate and/or oversee projects, and prepare regulatory documentation for submission to regulatory agencies, commercial partners and/or clients, including but not limited to SOP’s, ingredient and finished product specifications, quality agreements, formulation reviews, quality program design/input, HACCP/HARPC Plans, FSMA Compliance, cGMP Training, and other investigation reports, study protocols, final reports reviews and submissions as directed.
• Define, manage and/or execute projects and prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to regulatory plans, investigational reports, professional opinions, study protocols, final reports, and related data.
• Cooperate with team members on shared projects as designated to ensure efficiency in time management, execution of the work, and correctness of any deliverables or communications as designated.
• Maintain regulatory files/database and other systems in good order and in compliance with project or regulatory requirements.
• Review changes to existing product formulations and Quality Systems to help define the requirements for regulatory compliance of individual clients.
• Maintain regulatory and scientific excellence by keeping current knowledge of FTC, FDA, USDA and other national regulations, guidance, and standards applicable to client products upon direction and/or as experience permits.
• Interface with regulatory agencies on behalf of clients involving regulatory actions or submissions in accordance with Project Leader requirements, company standards and Project Scopes.
• Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(es) and methodologies.
• Provide team and client leadership with guidance on compliance matters and regulatory operations with respect to known strategies and activities.
• Operate seamlessly within team in a project management-driven environment to keep all projects updated/current, reporting of billable time, and proper utilization of company software and resources to ensure traceability and accountability.
• Partici…