Job Overview
This role involves overseeing regulatory activities, providing guidance to the team and managing a small regulatory team.
The successful candidate will be responsible for leading, developing and managing the local Regulatory Affairs team to ensure high performance and collaboration.
* Team Leadership: Leadership Development: Develop and manage the local Regulatory Affairs team's training and development plans to ensure they meet their full potential.
* Regulatory Operations: Submission Planning: Plan, oversee and actively support the submission of new Marketing Authorisation Applications (MAAs), variations, renewals and other post-approval activities in the territories assigned.
* Regulatory CMC: CMC Management: Manage and maintain a comprehensive overview of Modules 2.3 and 3 of the dossiers across all applicable territories.
Key Responsibilities:
1. Lead Team Members: The successful candidate will lead, develop and manage the local Regulatory Affairs team, ensuring they deliver high-quality work and adhere to company policies.
2. Strategic Planning: Develop and implement strategic plans to drive business growth and improve regulatory compliance.
3. Project Management: Plan, oversee and actively support the submission of new Marketing Authorisation Applications (MAAs), variations, renewals and other post-approval activities.
About Us:
We are a global pharmaceutical company dedicated to delivering innovative solutions that improve patient outcomes. Our teams are passionate about what we do, and we're committed to making a difference in people's lives.