Description
Regulatory Affairs Project ManagerKey Responsibilities:
* Provide input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site
* Manage and maintain regulatory strategies, tools, timelines and dashboards
* Coordination of meetings with Global and Regional teams to discuss strategies and resolve issues
* Interfaces with the site (R&D and Operations authors)to ensure regulatory strategies are integrated into site projects
* Support the preparation of regulatory filings, as needed
* Identification of issues and factors that may implicate a regulatory strategy or activity
* As assigned, responsible for the strategy and execution of the site specific aspects of the preparation of CMC amendments and post market supplements
* Participation in Technical Transfer Teams, Global Regulatory Teams as required
Basic Qualifications:
* Masters Degree and 3 years of directly related experience or Bachelors' Degree and 5 years of directly related experience
Preferred Qualifications:
* Degree in Life Sciences discipline
* Experience in manufacture, testing (QC/QA or Clinical), or distribution in Biotech/Pharma industry
* Regulatory CMC experience
* Developed project management skills including the use of Microsoft Project, Good Presentation and organization skills
* Demonstrated success in working with teams across functions and regions
This is a great & exciting opportunity with a large scale company. If you would like to hear more please call me direct on for a confidential discussion or alternatively email direct.