What are the responsibilities and job description for the Senior Regulatory Leader position at Triveni Bio?
About Us
We're a pioneering biotech company working at the convergence of human genetics, antibody design, and precision medicine to develop novel treatments for immunological and inflammatory disorders.
Job Opportunity
We're seeking a highly experienced Director of Regulatory Affairs to join our team and lead the development and execution of regulatory strategies to support the advancement of our pipeline.
Key Responsibilities:
- Develop and execute global regulatory strategies to support preclinical and clinical development.
- Prepare and submit regulatory documents, including INDs/CTAs, in compliance with FDA, EMA, and other health authority requirements.
- Lead teams through successful health authority meetings and interactions, serving as the primary point of contact.
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.
