Regulatory Ops – QDS

Regulatory Ops – QA Regulatory Mgr., Sr. QA Regulatory Mgr.

Several full-time salaried positions 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, 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 QDS department you will be responsible for project ownership, clients’ support, as directed in areas of regulatory compliance: manufacturing operations, standard operating procedure writing/optimization, specification writing, auditing, training, product development support, regulatory due diligence, formulation reviews, regulatory operations compliance, quality documentation review/development, FSMA/HARPC Plan writing/reviews, cGMP Facility Audits as directed, 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 regulatory information, track and control documentation, proof-read and provide input on compliance works in accordance with daily operating practices and the regulations as cited under the applicable regulations relevant to the assigned projects.

General Duties and Responsibilities:

  • 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.
  • 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.
  • Participate as needed in tradeshows, conferences, and other industry-related events. 
  • Travel as needed/permitted to client facilities or other locations in direct support of assigned projects, or other company activities.

The primary obligations of the position are as follows:

  • Represent company correctly and professionally to clients and partners the services and manage the assigned accounts and projects to ensure requirements deliverables are met
  • Participate in scheduled company meetings and provide colleagues/management with updates to project status, changes of scope, customer and/or regulatory feedback, scheduling and priority of tasks and general input on account development strategies
  • Maintain corporate, project and client confidentiality at all times, indefinitely
  • Adhere to communicating and conducting oneself in a professional manner at all working times, and maintain excellence in writing and interactions with clients and colleagues alike to drive individual, team and client successes

Corporate culture to which the individual must adhere:

  • 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 ones role through sound governance, responsible use of resources and participation in the industry

Qualifications:

  • BS in a scientific field is required. MS, Ph.D. (preferred).
  • Minimum of 10 to 15 years’ experience in Quality Assurance within the Food & Beverage, Dietary Supplement, Cosmetic and/or Homeopathic industries.
  • Extensive knowledge in FDA, FTC, USDA regulations. Knowledge of FDA CFR 21 Part 11, Part 111 and Part 117.
  • Must be able to handle multiple projects.
  • Proficient in MS Team, Word, Excel and Adobe.

Total Target Compensation:

  • Based on qualifications, experience, and interview performance. Performance based role (base salary with quarterly/annual bonuses based on billing targets)

100% Paid Benefits for Employees:

  • 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 on top of allocated Paid Time Off (PTO) Days 
  • Several other life benefit services and insurance options available e.g. Financial Planning, Counseling Services, etc.

If you are interested in applying for this position, please email your resume to: info@rejimus.com