Senior Director, Regulatory Affairs CMC

1w1 week ago

Tango Therapeutics

Boston, US · Full-time · $232,800 – $349,200

About this role

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering precision medicine for cancer treatment. It leverages synthetic lethality to target critical cancer vulnerabilities, including tumor suppressor gene loss. The Senior Director, Regulatory Affairs CMC leads global CMC regulatory strategies across the portfolio.

This role reports to the Chief Regulatory Officer and drives development of CMC content plans aligned with scientific principles and risk-based approaches. Responsibilities include planning and delivering high-quality regulatory submissions like IND/CTA, NDA/MAA. It ensures strategies meet global requirements throughout the product lifecycle.

The position partners cross-functionally with technical and program teams to assess risks and develop mitigations. It provides regulatory assessments for chemistry, manufacturing, and controls changes. Collaboration focuses on HA interactions and inspections for successful outcomes.

Tango's labs and offices are in Boston's Fenway area at 201 Brookline Avenue. The role offers opportunities to refine strategies with emerging data and negotiate with Health Authorities. It supports efficient development from discovery to post-approval changes.

Requirements

Advanced degree with 12+ years of experience developing CMC regulatory strategies
Deep expertise in product development and global regulatory strategy; recognized subject matter expert in CMC
Experience leading interactions with Health Authorities
Experienced leader with demonstrated track record of driving results
Strong knowledge of global HA laws, regulations, guidance, and submission pertaining to CMC
Strong understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
Experience communicating cross-functionally and defending CMC regulatory strategy
Hands-on experience submitting multiple NDAs/MAAs for new chemical entities and lifecycle management

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
Ensure the CMC development strategy meets global regulatory requirements for registration and lifecycle
Drive preparation of dossiers for submission to Health Authorities (NDA/MAA/IND/CTA and post-approval changes)
Provide accurate regulatory assessments of chemistry, manufacturing and controls changes
Effectively communicate with Health Authorities and maintain good rapport
Determine timing and strategy for HA meetings, prepare staff, and lead CMC discussions
Provide CMC regulatory support to health authority inspections