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
- 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.
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)
- Regulatory Affairs Certification (RAC)