Regulatory Affairs Manager
This role is ideal for a professional with experience in EU regulatory frameworks, clinical development, and oncology drug development programs. Key responsibilities include developing regulatory strategies, managing CTA submissions, organizing and reviewing regulatory documents, performing critical analyses of clinical and preclinical data, leading EU scientific advice requests, and monitoring newly published EU Commission and EMA guidelines.
Requirements
* A proven ability to navigate EU regulatory frameworks and requirements.
* Detail-oriented and skilled in analyzing clinical and preclinical data.
* Experience leading regulatory agency meetings and negotiating effectively with stakeholders.
* Passionate about contributing to oncology drug development programs.
* Values continuous learning and stays updated on emerging regulatory trends.
What We Offer
Our company offers a collaborative environment, opportunities for growth and development, and comprehensive benefits including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
As an equal opportunity employer, we are committed to fostering an inclusive and diverse culture that provides reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment.