Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

Top biotechnology (BioTech) company developing innovative treatments

Industry
Biotechnology

Type
Privately Held

About the Role

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, and MAAs. The role also requires staying abreast of and interpreting changes in regulations, guidelines, and legislation, as well as providing guidance on compliance issues and potential risks. The Head of Regulatory Affairs will be expected to collaborate with cross-functional teams to ensure that regulatory requirements are integrated into development plans, clinical trials, and manufacturing processes. Additionally, the role involves risk assessment, mitigation, and the development and maintenance of standard operating procedures and regulatory policies to ensure ongoing compliance.

Functions

• Operations