Join a Community Focused on Ground-Breaking Treatments
We are dedicated to transforming lives through innovative medicines.
Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases.
This role offers the opportunity to play a meaningful part in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our development programs in metabolism and ophthalmology.
This is an exciting chance to make a positive impact on patients' lives while collaborating with elite scientists and regulatory professionals.
* Develop and implement regulatory strategies for assigned projects in collaboration with global development teams.
* Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states.
* Lead regulatory activities such as CTA amendments, annual reports, and other key submissions.
* Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making.
* Review clinical protocols and study reports to ensure alignment with EU regulatory requirements.
* Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies.
* Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed.
This role may be suitable for you if:
* You thrive on developing and implementing regulatory strategies that drive innovation and compliance.
* You have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA.
* You are passionate about advancing groundbreaking treatments in metabolism and ophthalmology.
* You excel in establishing relationships and influencing collaborators across diverse teams.
* You are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents.
* You enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals.
* You are proactive in staying informed about emerging regulatory trends and guidelines.