Job Title: Regulatory Affairs Professional
We are seeking a highly skilled Regulatory Affairs Manager to support our development programs and ensure compliance with emerging EU legislation. As a key member of our team, you will be responsible for developing and implementing EU-appropriate regulatory strategies for clinical development and product approvals.
A typical day in this role may involve leading regulatory activities for clinical study start-up and maintenance, including submissions and addressing agency queries. You will also oversee Marketing Authorization Application (MAA) processes to secure timely product approvals with competitive labelling.
To succeed in this position, you must have a strong understanding of EU regulatory systems and processes. Additionally, you should excel at developing and executing regulatory strategies for clinical development, as well as being detail-oriented when managing compliance issues and agency interactions.
As part of our global regulatory team, you will collaborate closely with cross-functional teams to achieve business objectives while ensuring alignment with company policies.