What are the responsibilities and job description for the Director of Global Compliance position at Triveni Bio?
Job Description
The Director of Regulatory Affairs is responsible for leading the development and execution of regulatory strategies to support the advancement of Triveni's pipeline.
Key Responsibilities:
- Provide regulatory leadership and guidance to program teams by developing and executing on global regulatory strategies that support preclinical and clinical development.
- Prepare for and lead teams through successful health authority meetings and interactions, serving as the primary point of contact with regulatory agencies.
- Ensure adherence to global regulatory requirements, identify potential risks, and proactively develop mitigation strategies.
- Establish best practices and contribute to the continuous improvement of the regulatory infrastructure as the company grows.
Requirements:
- BA/BS with at least 10 years of experience in regulatory affairs with the biotechnology or pharmaceutical industry.
- Strong knowledge of FDA, EMA, and other global regulatory requirements.
- Proven track record of leading successful IND/CTA and/or BLA/NDA/MAA submissions.
