Title: Regulatory Manager
Department: Quality Development Services(QDS)
Reports to: COO
As the Regulatory Manager in Quality Development Services (QDS) with REJIMUS, a preeminent regulatory management consulting firm to the Food, Dietary Supplement, Cosmetic and Homeopathic industries, you will be responsible for providing both team participation, project/task ownership, management support as requested or assigned and support for clients as directed in areas such as manufacturing operations, product development, regulatory due diligence, formulation reviews, regulatory compliance, quality documentation review/development, FSMA/HARPC Plan writing/reviews, cGMP Facility Audits, registrations in US and foreign 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 regulatory information, track and control documentation, proof-read and provide input on compliance 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.
This is a full-time office-based position at REJIMUS that requires absolute security of all company provided equipment(s), company information and customer information, whether in electronic or any other format. Reliable access to the Internet and preservation of all assigned equipment(s) is required and office resources will be provided as needed to ensure productivity. Moreover, the position requires you to maintain strict control over your dedicated working environment/space, inclusive of the ability to mitigate surrounding noise or distractions while conducting work inclusive of customer communications e.g. teleconferences, video conferencing, etc. As company resources are available, such resources can be utilized, as REJIMUS deems necessary. The position requires occasional overnight travel to customer locations whether in state, out-of-state and/or internationally in order to render services. You are required to maintain sufficient and current documentation and/or identification at all times in order to fulfill the obligations for any services that require such travel. Travel on behalf of REJIMUS to tradeshows or conferences and other opportunities whereby you will represent REJIMUS may also be required from time to time. In the event of traveling for any assigned work outside of your primary residence, which is determined to be a radius of thirty (30) miles or more, any and all expenses, whether due reimbursable by REJIMUS or due reimbursable by customers, must be reviewed and approved in advance by REJIMUS, inclusive of mileage, and must be properly submitted to REJIMUS for review and approval prior to reimbursement.
The general duties and responsibilities of the position are as follows:
• Write, review, collect, coordinate and/or oversee projects and tasks, and prepare regulatory documentation for submission to regulatory agencies or to 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 and tasks as directed.
• Travel as needed to clients’ facilities or other locations to directly support assigned projects or tasks, or other company activities e.g. tradeshows, etc.
• Maximize individual billability and maintain timely (at minimum daily at the close of business or upon each task completion) compilation of billable time and materials for any assigned work or licenses and/or registrations.
• Work with the executive management to build and manage departmental teams within the company to accomplish company defined goals and financial objectives.
• Maintain regulatory files/database in good order; help establish and maintain project management system for tracking changes in documents submitted to agencies or partners.
• Provide ancillary support and back-up reviews for formulas, labeling practices and labels for compliance with regulatory requirements e.g. structure-function claims and other allowable claims categories whether in the US or other designated countries as needed.
• Maintain current knowledge of FDA, FTC, USDA and other international regulations, guidance and standards applicable to client products.
• Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(s), methodologies, etc.
• Provide team and client leadership and training as needed with guidance on compliance matters and regulatory operations with respect to known strategies and activities or operations.
• Participate in research of regulatory issues and dissemination information to team members for in-person, teleconference and other communications with client or partners as required.
The primary principles of the position are as follows:
• Represent company to clients and partners on quality matters and manage assigned projects and/or tasks and team members to ensure all regulatory or quality requirements are met to ensure compliance of client operations.
• Review company material(s) and communications for appropriateness and compliance to regulatory requirements and laws.
• Provide colleagues with updates to projects, changes of scope, customer actions and/or other regulatory feedback as received and qualified.
• Maintain corporate and client confidentiality at all times, adhere to conducting oneself in a professional manner at all times and maintain excellence in writing and communication with clients and colleagues alike.
Corporate culture to which the individual must adhere:
As a member of REJIMUS, you agree to embrace and live out the core values of REJIMUS, which are specifically to:
• Provide services and advice that uphold the safety of end consumers
• Work with integrity, represent with dignity and treat all with respect
• Co-create a work environment that encourages continual learning and professional growth of colleagues and clients alike
• Strive for ongoing company successes through fostering healthy partnerships and long-term customer relationships
• Exemplify corporate stewardship in one’s role through sound governance, responsible use of resources and participation in the industry
To apply, submit your resume and cover letter to: email@example.com