Director of Regulatory Affairs
: Job Details :

Director of Regulatory Affairs

About the Company

Join a leading biotechnology company that is at the forefront of developing groundbreaking treatments.

Industry Biotechnology

Type Privately Held

About the Role

We are looking for a dynamic Director of Regulatory Affairs to spearhead the strategic leadership and oversight of all regulatory activities. This vital position will shape the regulatory strategies that align with regional and global standards, particularly those established by regulatory authorities. The ideal candidate will provide essential regulatory insights to both non-clinical and clinical development programs, lead the crafting of a variety of regulatory submissions, and serve as the primary liaison for regulatory agencies.

Key Responsibilities:

• Oversee the preparation, review, and submission of a comprehensive array of regulatory documents, including INDs, NDAs, BLAs, and MAAs.
• Stay informed on and interpret evolving regulations, guidelines, and legislation.
• Advise on compliance issues and identify potential risks.
• Collaborate with cross-functional teams to seamlessly integrate regulatory requirements into development plans, clinical trials, and manufacturing processes.
• Conduct risk assessments and devise mitigation strategies.
• Develop and maintain standard operating procedures and regulatory policies to ensure continuous compliance.

Travel Percent Less than 10%

Functions

• Operations
• General Management