Senior Director, Regulatory Affairs
Watertown, MA
Development – Clinical /
Full-time /
On-site
COMPANY INTRODUCTION
Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.
SUMMARY
Triveni Bio is searching for our first Regulatory Affairs hire. In this role, you will have the opportunity to make a significant impact at a dynamic and fast-growing company that is dedicated to developing antibody therapeutics for novel disease targets. The Sr. Director of Regulatory Affairs, will have direct responsibility for the development and execution of regulatory strategies to support the advancement of Triveni’s pipeline, ensuring compliance with global regulatory requirements. This role requires a hand-on leader who can manage regulatory submissions, interact with health authorities, and collaborate with internal teams and external partners to drive key regulatory milestones.
KEY RESPONSIBILITES
· Provide regulatory leadership and guidance to program teams by developing and executing on global regulatory strategies that support preclinical and clinical development.
· Lead the preparation, submission, and maintenance of regulatory submissions including INDs/CTAs, in compliance with FDA, EMA, and other health authority requirements.
· Prepare for and lead teams through successful health authority meetings and interactions, serving as the primary point of contact with regulatory agencies.
· Work closely with R&D, clinical, and external partners to integrate regulatory considerations into development plans.
· Ensure adherence to global regulatory requirements, identify potential risks, and proactively develop mitigation strategies.
· Continuously monitor the evolving regulatory landscape and emerging trends, assess potential impact, and provide recommendations to leadership.
· Establish best practices and contribute to the continuous improvement of the regulatory infrastructure as the company grows.
EXPERIENCE & QUALIFICATIONS
· BA/BS with at 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.
· Broad understanding of biopharmaceutical drug development with experience in immunology/inflammation clinical development and antibody therapeutics preferred
Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.
