Position Summary:
We are seeking a dedicated Regulatory Affairs professional to join our team and contribute to the development of our generic's portfolio. As part of our Global Regulatory Affairs function, you will play a key role in ensuring that our medicines reach patients safely and efficiently.
The ideal candidate will possess excellent leadership and coordination skills, with experience in regulatory activities for pharmaceutical portfolios. You will be responsible for leading and managing European procedures, providing regulatory support for international pharmaceutical marketing authorisations, and collaborating with cross-functional teams and regulatory authorities.
Main Responsibilities:
* Lead regulatory strategies and manage submissions across Europe and beyond
* Coordinate regulatory activities for medicines portfolio
* Plan and manage European procedures (MRP/DCP)
* Develop and execute strategic planning and lifecycle management in and outside Europe
* Collaborate with internal stakeholders to ensure regulatory strategies align with business goals