What are the responsibilities and job description for the Regulatory Affairs Director position at Triveni Bio?
About Triveni Bio
We're a biotech company pioneering precision medicine approaches to develop functional antibodies for treating immunological and inflammatory disorders.
Our Approach
We adhere to core values: patient impact, rigorous science, open collaboration, and kindness. Our lead program targets kallikreins 5 and 7 to address atopic dermatitis and other barrier disorders.
Role Overview
The Director of Regulatory Affairs will lead the development and execution of regulatory strategies to advance our pipeline, ensuring compliance with global regulations.
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.
- Work closely with R&D, clinical, and external partners to integrate regulatory considerations into development plans.
