REGULATORY SENIOR ADVISOR
Title: Regulatory Sr. Advisor
Department: Regulatory Guidance Services (RGS)
Reports to: COO
As a Regulatory Sr. Advisor in Regulatory Guidance Services (RGS) with REJIMUS, a preeminent regulatory management consulting firm to the Food, Animal Feed, Dietary Supplement, Cosmetic and Homeopathic industries, you will be responsible for providing leadership, team development and direct hands-on support for projects, industry specific clients and related requests thereof in areas such as strategic planning and management, product development, regulatory applications, litigation consulting, regulatory agency actions, regulatory filings (e.g GRAS, NDIN, etc.), claim evaluations and substantiation(s), quality system optimization, clinical study design/support, and facility auditing where/how applicable. You will organize regulatory information, track and control documentation, advise on compliance strategies and quality or regulatory operations for organizations worldwide in accordance with the daily operating practices of REJIMUS, the FDA regulations as cited under 21CFR Part 111, 110 (Part 117) and 101 and other applicable governing regulations (either domestic or international) based on the project(s) to which you may be qualified for and assigned. Must adhere to and work well within a project management work environment using novel technologies/systems and team structure(s), to meet project deadlines within budget as well as accomplish department, corporate and client goals.
This full-time position based at the US headquarters for REJIMUS that requires absolute security of all company provided equipment(s) or assigned account(s) and system(s), company information and customer information, whether in electronic or any other format. Reliable access to the Internet with sufficient bandwidth and mobile phone reception/access is required for offsite individuals. Moreover, the position requires strict control over dedicated working environment/space, inclusive of the ability to mitigate surrounding noise while conducting work inclusive of customer communications e.g. teleconferences, video conferencing, etc. As company provided resources are made available, such resources can be utilized, as REJIMUS directs and deems necessary for the position. The position will occasionally require 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, legal standing 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 will also be required from time to time. In the event of traveling for any assigned work outside the headquarters, 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:
• Define, managed 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 regulator plans, investigational reports, professional opinions, study protocols, depositions, final reports and related data.
• Travel as needed/permitted to clients’ facilities or other locations to directly support assigned projects or tasks, or other company activities.
• Maintain daily compilation/submission of all billable time and materials/expenses for any assigned work, communications and other billable time.
• 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 and other systems in good order and in compliance with project or regulatory requirements.
• Review changes to existing product formulations and Quality Systems to define the requirements for regulatory compliance.
• Function as lead for all development efforts and assembly of GRAS, NDIN or other regulatory-sensitive projects subject to agency notification/submission as qualified to support; liaise with client and client defined vendors to ensure program success.
• Provide Litigation Consulting services based on area expertise as retained/available, inclusive of Expert Witness Testimony support, as needed.
• Responsible for accomplishing/managing all assigned client tasks directly and through use of team members, client personnel and/or other contracted third parties as permitted.
• Maintain regulatory and scientific excellence by staying current knowledge of FDA and international regulation, guidance and standards applicable to client products.
• Actively participate in the evaluation of regulatory changes affecting industry compliance of documentation, product(s), process(s), methodologies, etc.
• Provide team and client leadership with guidance on compliance matters and technical or regulatory operations with respect to Regulatory, Quality, Sales and Marketing activities and support for such designated personnel.
• Participate in team research of regulatory issues and dissemination information to team members for continual education via in-person, teleconference and other communications with client or partners as required.
The primary principles of the position are as follows:
• Represent company to agencies, clients and partners on regulatory matters and manage assigned projects and/or tasks and team members with the utmost of professionalism to ensure all regulatory or quality requirements are met to ensure overall quality and compliance of services and work products.
• Ensure company material(s) and communications are appropriate and/or compliant with regulatory requirements and laws.
• Provide colleagues with experiential insights and updates to projects, changes of scope, customer actions and/or other regulatory feedback.
• Maintain corporate and client confidentiality at all times.
• Adhere to conducting oneself in a professional manner and maintain excellence in writing and communication with clients and colleagues alike.
As a member of the Regulatory Guidance Services team and management of REJIMUS, the you agree to embrace and live out the core values of REJIMUS’s corporate culture, and more 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 relationships.
• Exemplify corporate stewardship through sound governance, responsible use of resources and participation in the industry.
The Regulatory Principal will have achieved an executive level management experience and recognized industry involvement, and be comfortable in participating in industry-specific forums, including documented having scientific accomplishments along with key trade associations and other expert panel/forum participation or speaking opportunities.
An applicable level of professional expertise entails:
• Required: MS, Pharm.D. or Ph.D. level degree in Food Science, Chemistry, Medicine, Pharmacognosy, Clinical Research, Biology or other related scientific discipline required and/or experience equivalent; JD is highly encouraged.
• 15+ years in the food, dietary supplement or cosmetic industries operating in and managing within the areas of Quality Assurance, Regulatory Affairs and/or Government Affairs in an applicable industry within the US; additional international regulatory agency expertise is strongly preferred.
• Fluent in latest Microsoft Office, Adobe and designated Project Management Software(s).
• Required: Development, management and submission of GRAS and NDI Notifications.
• Required: Documented FDA Interaction/Communications, Litigation Consulting and Expert Witness Testimony experience.
• Prior consulting experience in the areas Regulatory Affairs or Government Affairs is strongly preferred.
To apply, submit your resume and cover letter to: email@example.com