Senior Director, Regulatory Affairs

About the role

• Responsible for managing a team of four regulatory professionals and the submission of product registrations domestically and internationally. Interacts and negotiates with regulatory agency personnel to expedite approval of pending registration. Serves as a regulatory leader on the project team which includes R&D, Quality, Operations, Marketing and Sales in new product registrations and existing product marketing. Provides advice on manufacturing changes, specifications, technical labeling, marketing, and appropriate regulations.  This role is a critical member of the Operations Leadership Team, reporting directly to the COO of the company. 

What you'll do

• Supervisory Responsibilities
  • All members of the Regulatory Department (4 team members).
• Duties and Responsibilities

  • Partner with sales teams to develop strategies for regulatory approval of food/dietary supplements and cosmetics worldwide based on business needs;

  • Partner with R&D and operations team on the development of new products;

  • Organize project teams, initiate project schedules, and provide project leadership worldwide to achieve desired regulatory outcomes within defined timeframes;

  • Prepare global regulatory applications for domestic and other international markets, such as Latin America, Canada; maintain regulatory files as required by departmental procedure;
    

  • Interact with the U.S. FDA and other regulatory authorities worldwide;

  • Ensure Adverse Event reporting to the FDA; participate in Complaint System;

  • Review advertising materials for compliance with global regulations; analyze and recommend appropriate changes;

  • Participate in Risk Management assessments;

  • Review design and manufacturing changes for compliance with applicable regulations;

  • Oversee documentation to support Product Dossiers to ensure accuracy, applicability, consistency, and control of regulatory documents;

  • Support audits by government agencies;

  • Hire, mentor, and train regulatory staff; engage outside consultants, as needed;

  • Work with R&D, Operations, Sales, Marketing and Quality on new product launches in the markets under your responsibility. 

Qualifications

• Required Skills and Abilities
  • Strong interpersonal and communication skills.
  • Strong leadership and strategic skills.
  • Proficient in Microsoft Office Suite. 
  • Ability to review technical files with accur