Job Details

Regulatory Senior Advisor

Company name

Ingredient Identity

Organization Type


Job Type


Date Last Verified

May 14,2019

Valid Through

Aug 27,2019

Posted on

Feb 12,2019

Years of Experience

Min 5 yrs required


Santa Ana, CA, United States

Employment Type



Practice Area
Food & Drug Administration >> Food & Drug Administration
  Employer Sponsored Job (Free to apply to)
38 hits 1 times Apply


Regulatory Senior Advisor
The candidate 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. 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 Ingredient Identity, 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 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. 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. 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 Ingredient Identity, the agree to embrace and live out the core values of firm’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. 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.

Qualification and Experience

The candidate should have 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. Must have 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. Must be 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.

Company info

Hiring Coordinator
Ingredient Identity
600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701

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