Vice President, Regulatory Affairs

About TRIANA Biomedicines

TRIANA Biomedicines is a Greater Boston biotechnology company building the leading molecular glue discovery platform to regulate disease targets that are difficult to address with any other modality. TRIANA’s drug discovery engine is powered by high-resolution structural insights, state-of-the-art AI and computational tools, and bespoke chemical libraries. TRIANA’s target-first and rational approach to molecular glue discovery is currently focused on inducing or enhancing the degradation of high-profile cancer targets. The therapeutic approach pioneered by TRIANA has the potential to fundamentally change the paradigm of small molecule drug discovery and bring significant therapeutic benefits to patients. TRIANA is a private company with a top-tier investor syndicate.

As we advance our programs into the clinic, we are seeking a talented regulatory leader who is able to move fluidly between regulatory strategy discussions and making it all happen. You will be our first regulatory hire to join our team. Come be a part of shaping our global regulatory strategy and supporting our programs through development.

The Vice President of Regulatory Affairs will be responsible for developing and executing global regulatory strategies to support the advancement and approval of our product candidates. This role will provide strategic leadership, ensure regulatory compliance, and serve as the primary point of contact with regulatory agencies including the FDA, EMA, and other international authorities.

Key Responsibilities

• Lead the design and execution of global regulatory strategies across all phases of product development, with a primary focus on oncology indications.
• Oversee the preparation and submission of regulatory documents, including INDs, CTAs, NDAs, briefing books for consultations and MAAs.
• Represent the company in regulatory agency interactions, including meetings, briefings, and inspections.
• Serve as a strategic advisor to executive leadership and cross-functional teams on regulatory risks, opportunities, and timelines.
• Take the lead in ensuring all aspects of regulatory documents are prepared to the highest quality supporting aggressive timelines.
• Partner with the other members of the development team in all aspects of bringing a drug from preclinical to patients.
• Oversee the work of external consultants and partners as relevant.
• Monitor global regulatory trends and changes in oncology-related guidance to ensure proactive strategy adjustments.
• Ensure company compliance with applicable regulations and guidances governing pharmaceutical development.

Qualifications

• Advanced degree (Ph.D., PharmD, MD, or equivalent preferred) in a scientific or regulatory discipline.
• Minimum of 15 years of experience in regulatory affairs in the biotech or pharmaceutical industry, with at least 8 years in oncology biotech.
• Proven track record of designing successful regulatory strategies, including IND, NDA, or MAA submissions and approvals, as well as agencies' consultations.
• Experience building and managing highly efficient teams, including consultants.
• In-depth knowledge of FDA and EMA regulatory requirements and oncology development pathways. Experience with other global regulatory agencies is a plus.
• Excellent communication and negotiation skills.

We welcome applications from skilled individuals whose qualifications may not fit the criteria outlined above. Salary range for this role: $250k-$290k

Our Culture

Our Team is our greatest asset at TRIANA. We are proud to work with an integrated group of individuals from an extensive range of backgrounds and experiences. Diversity, Equity, Inclusion and Belonging are important aspects of our culture. We embrace our differences and cultivate an environment that drives better collaboration and innovation by striving to ensure that all coworkers have an ongoing positive experience while being their authentic selves.

Our Values

At TRIANA we are empowered to act. We dare to create transformative medicines for patients. Our creativity and dedication are the glue that unites us in pursuit of our mission.

Thank you for your interest in TRIANA!