Description
Roles and Responsibilities:- Responsible for the preparation of regulatory submissions in compliance with global requirements. These will include Marketing Authorisation Applications, clinical trial applications, Orphan Drug Designation applications, Paediatric Investigational Plans, amendments, variations, annual reports etc
- Review and approve regulatory submissions, in particular CTAs prepared by CROs/consultants
- Participate in group meetings and provide status updates and strategy input to moderately complex aspects of the development programs
- Maintain up to date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact into the development programs
- Develop and maintain regulatory intelligence data particularly related to oncology products
Requirements:
- Requires a Life Science/Pharmacy degree in relevant discipline
- An advanced degree (MSc/PhD) is desirable
- Minimum of 5+ years of regulatory experience is required
To find out more about Real please visit www.realstaffing.com