Global Regulatory Team Lead
Our client is a multinational pharmaceutical and healthcare company that aims to build a healthier and more resilient work by ensuring access to healthcare for the world’s poorest people.
As Global Regulatory Team Leader, you will be responsible for the management and delivery of global regulatory activities for assigned projects in accordance with regulatory requirements. You will provide support to the regulatory strategy as needed in product development, this support will include both strategic and operational activities.
- Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as Clinical Trial Applications (CTA)/ Investigational New Drug (IND), amendments, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
- Attending and participating in the assigned project/regulatory product development and submissions teams, providing clear and consistent regulatory recommendations.
- Track regulatory project status and informational documents.
- Coordinate required documentation in coordination with Chemistry, Manufacturing and Controls (CMC) Team or Functional group.
- Creating timelines and tracking deliverables to timeliness to ensure that all submissions are submitted on-time.
- Master of Science in Life Sciences (i.e. Pharmacy, Chemistry or Biology). Master of Science in Management Sciences or Life Sciences is preferred.
- 6-8 years of regulatory experience with basic regulatory knowledge of EU and US.
- Ideally experience in Big/Major pharma.
- Investigational New Drug/ Clinical Trial Applications experience.
- Solid oral communication and writing skills in English.
- A dynamic person and good team player who can adapt to different settings and ability to work well within cross functional teams.
Are you ready for a new opportunity? This is your chance! If you are interested click the apply button bellow and I will get in contact with you as soon as possible.