Global Regulatory Expert
As a Global Regulatory Expert, you will play a pivotal role in developing and executing global regulatory strategies. This encompasses ensuring timely, compliant submissions for a diverse product portfolio.
* Lead or support the development of regulatory strategies for new Market Authorization Applications (MAAs) and post-approval changes
* Collaborate closely with local regulatory teams and Health Authorities to foster effective partnerships
* Prepare and review comprehensive dossiers and submission components, guaranteeing compliance with regulatory requirements
* Maintain accurate and up-to-date regulatory databases and project records, facilitating efficient decision-making
* Establish strong relationships with internal stakeholders and external partners, fostering open communication and collaboration
About You:
We are seeking an individual with a Degree in Life Sciences/Pharmacy (Master's or Ph.D. being a plus) and substantial experience in Regulatory Affairs.
Key skills required include ability to work independently and collaboratively, excellent analytical and problem-solving skills, and proficiency in maintaining complex databases and records.