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Director, Regulatory Compliance

4 months ago

North Brunswick, United States USPL Nutritionals, LLC. Full time
Job DescriptionJob Description

Job Description

Date

08/2023

Location

1300 Airport Road, North Brunswick NJ

Title

Director, Regulatory Compliance for Dietary Supplements & Vitamins

Department

Research & Development

Reports to

Executive Vice President

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

USPL Nutritionals is currently recruiting for Director, Regulatory Compliance for Dietary Supplements & Vitamins. This position reports into the Executive Vice President and is based at North Brunswick, NJ. This position is accountable to provide strong leadership that enables robust regulatory strategies that align across Quality Assurance, Quality Control, R&D and Manufacturing teams and with a focus on assuring that new products meet company and regulatory standards. This position will monitor the regulatory environment for changes in regulatory requirements related to supplements, food, and other product classifications.

This position also supports regulatory inspections and certification audits relevant to dietary supplement registration and compliance in the Company’s subsidiary markets.

Areas of Responsibility

  • Provides input during Design, Development, and Launch Activities driving alignment related to product and process validation strategy, specification, and test method harmonization strategy.
  • Oversees and/or provides input to quality activities related to new products and project changes including change controls.
  • Leads resolution of issues and represents as member of the issue response teams and during post market events related to dietary supplement products.
  • Works closely with R&D and Sales & Marketing to ensure appropriate communication, escalation and prioritization of issues. This includes monitoring and communicating external developments and creating regulatory strategies to enable successful market entry.
  • Keeps current on the trends in the marketplace, with the competition, and in the organization.
  • Other duties as assigned.

Other Responsibilities Including Safety:

  • Complies with all job-related safety and other training requirements.
  • Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

  • Bachelor’s degree from an accredited institution in a related field. Post graduate degree preferred.
  • A minimum of 4 – 15 years of experience in a QA role or regulatory role, (with plant QA experience preferred) in either Food and Dietary Supplements Production, Pharmaceutical, Medical Device, OTC Drug, and/or Cosmetics.

Certifications, Licenses, Credentials:

  • N/A

Skills & Ability:

  • Expert knowledge of cGMP and cGLP requirements.
  • Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.
  • Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
  • Excellent influence, persuasion, communication, and presentation skills.
  • Provides technical direction to others and ensures that execution delivers on targeted goals.
  • Keeps accurate documentation and submits detailed reports to appropriate executives.
  • High attention to detail, organization and accuracy.
  • Ability to think strategically and to creatively translate strategy into action.
  • Contributes to policy, strategy implementation, and execution of relevant policies and procedures.
  • Develops strategies that position the business to shape and to capitalize on emerging market needs and regulatory requirements.

Physical Requirements (lifting, etc.):

  • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees.

Work Environment (Office, Warehouse, temperature extremes, etc.):

  • Primarily located in an office environment where temperatures are controlled for heat and air conditioning; occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.