Head of Regulatory Affairs

Top biotechnology (BioTech) company developing innovative treatments

Biotechnology

The Company is seeking a Head of Regulatory Affairs to provide strategic leadership and oversight of all regulatory activities related to the development and registration of its products. This critical role involves the development and execution of regulatory strategies that ensure compliance with regional and global requirements, particularly those set forth by regulatory authorities. The successful candidate will be responsible for providing regulatory strategic input to non-clinical and clinical development programs, leading the preparation of various regulatory submissions, and serving as the primary point of contact for regulatory agencies.
Key responsibilities for the Head of Regulatory Affairs at the company include organizing and overseeing the preparation, review, and submission of a range of regulatory documents, such as INDs, NDAs, BLAs, a...