Director of Global Regulatory Affairs

Summary:

Responsible for directing the strategy, development, implementation and monitoring of complex regulatory policies and programs.

Essential Duties and Responsibilities:

  • Responsible for post market surveillance activities
  • Provide general direction, tactical objectives, and functional plans for execution of Regulatory Affairs Department
  • Develop, communicate, and track goals necessary to the success of the Regulatory Affairs Department, as it relates to the success of the Company
  • Responsible for monitoring product safety as well as adverse event assessment and reporting
  • Responsible for Global Product Registration as required by applicable laws and regulations
  • Implement and monitor the Corporate Audit Program
  • Responsible for Regulatory Affairs Special Processes not otherwise listed.
  • Ensures that all policies and strategies are in full compliance with all applicable regulatory requirements while still maintaining operational efficiency for the company
  • Regularly consult with business leaders to develop corrective action plans
  • Effectively manage change to ensure compliance with regulatory affairs
  • Work is accomplished through managers, principles, specialists, and associates
  • Provides guidance to subordinates to achieve goals
  • Exercises the usual authority of a manager including selection and development of staff

Ability to:

  • Collaborate, influence and build strong sustainable business relationships with various functions and levels throughout the organization.
  • Clearly and concisely communicate orally and in writing to individuals and groups in a compelling manner.
  • Make decisions using insights, data, and cross functional collaboration inputs.
  • Adapt and support the organization through times of change.
  • Assess business views strategically.
  • Precisely and proficiently conduct business and data analyses and forecasts with data driven recommendations for improvements and advancements.
  • Operate and use telephones, computers/laptops and other technological devices/software programs to communicate with other people.
  • Proficiently use and perform key functions of Microsoft Excel software program.

Qualifications:

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelor's degree in analytic field or equivalent.
  • 15+ years relevant regulatory experience
  • Previous people management experience.
  • Proficient in Microsoft Office Suite (Excel, Word, and Power Point)
  • Oracle experience as an ERP preferred (Inventory, MRP, ASCP)

Preferred Skills

  • MBA
  • Regulatory Affairs Certification (RAC)

Job Type
Full-Time Regular
Location
Dallas TX