Senior Director, Regulatory Affairs CMC

Tango Therapeutics • Boston, MA

11h • Hybrid

About The Position

The Senior Director, Regulatory Affairs CMC, reporting to the Chief Regulatory Officer, is responsible for leading the development and execution of global CMC regulatory strategies and content plans across the Tango portfolio, ensuring alignment with scientific principles and risk-based approaches. This role drives the planning, preparation, and delivery of high-quality CMC regulatory submissions, partners cross-functionally with technical and program teams, and provides strategic guidance to support efficient development and successful regulatory outcomes across all stages of the product lifecycle.

Requirements

• Advanced degree with 12+ years of experience developing CMC regulatory strategies, with deep expertise in product development and its application to global regulatory strategy; recognized as a subject matter expert in CMC development
• Experience leading interactions with Health Authorities
• Experienced leader with a demonstrated track record of driving results and achieving success
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission pertaining to CMC development and registration topics
• Strong understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Experience in communicating cross-functionally. Presents and defends CMC regulatory strategy and opinion to project teams; recognizes global regulatory impact
• Hands on experience in submitting multiple NDAs / MAAs for a new chemical entity and managing the registration process and life cycle management
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion

Responsibilities

• Develop and execute global CMC regulatory strategy for all Tango products. Refine regulatory strategy as new data become available and re-assess as necessary. Assess regulatory risks and develop mitigations plan, when applicable.
• Develop and get buy-in on regulatory CMC strategy for Health Authority (HA) responses as needed.
• Ensure the CMC development strategy meets global regulatory requirements for registration and over the lifecycle of the product.
• Drive and be accountable for the preparation of dossiers for submission to Health Authorities (NDA/MAA/IND/CTA and post approval changes). Work with the CMC team to develop CMC content and submission plans. Develop strategy for providing responses to HA questions (ensure alignment with CMC functions and global strategy).
• Provide accurate regulatory assessments of chemistry, manufacturing and controls changes to teams/projects and execute regulatory planning and implementation.
• Effectively and tactfully communicate with HA; maintain good rapport and credibility with HA.
• In collaboration with Regulatory Leader, as applicable, determine timing and strategy for HA meetings, prepare company staff for interactions, lead CMC meetings with Health Authorities. Ability to negotiate with HA personnel.
• Provide CMC Regulatory support to health authority inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees