Director, Regulatory Systems and Operations

Tango Therapeutics•Boston, MA

2d•Hybrid

About The Position

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts. The Director, Regulatory Systems and Operations, reporting to our Chief Regulatory Officer, serves as a strategic leader and driver of regulatory infrastructure and execution. This role partners cross-functionally with internal stakeholders to define, implement, and continuously enhance Regulatory Information Management (RIM) systems and databases, ensuring the integrity, accessibility, and scalability of all regulatory information and documentation. In parallel, this leader plays a critical role within the global regulatory organization as co-lead of the Global Regulatory Subteam, with accountability for the strategic planning, coordination, and execution of regulatory deliverables. The Director ensures alignment of regulatory activities with development timelines and organizational priorities, driving cross-functional collaboration to deliver high-quality submissions on time. This position works closely with the Regulatory Strategy Leads to proactively shape and advance regulatory plans across the product lifecycle, providing both strategic oversight and operational leadership to enable successful global regulatory outcomes.

Requirements

Minimum of 10 years of Regulatory Operations experience
BA/BS or equivalent required
Strong knowledge of Veeva RIM systems
Demonstrated success in defining and implementing new operating standards and regulatory processes
Extensive experience in Regulatory Affairs project management within drug development, including leading cross-functional development teams
Deep expertise in regulatory publishing requirements and constraints, with hands-on experience managing submissions for IND, CTA, NDA, and MAA applications
Solid understanding of electronic document management systems, regulatory databases, publishing platforms, and related technologies
Self-motivated, adaptable, and innovative leader with the ability to prioritize, manage multiple projects, and thrive in a fast-paced, dynamic environment; strong problem-solving skills with the ability to develop and implement effective solutions
Strong organizational and project management capabilities
Excellent written and verbal communication skills, including presentation and facilitation

Nice To Haves

advanced degree preferred

Responsibilities

Lead the implementation and optimization of the Regulatory Information Management System (RIMS), ensuring strong user adoption through effective training and support.
Drive continuous improvement of regulatory processes and monitor key global metrics and compliance indicators to advance operational excellence.
Interface with Tango’s IT, QA and R&D departments and with external partners (if applicable) on local regulatory system management related topics.
Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide.
Build and maintain relationship with external vendor partners (e.g. publishing).
Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation.
Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to.
Lead project management activities related to the preparation and tracking of regulatory documents/submissions.
Co-lead and coordinate the Global Regulatory Sub-Team (GRST) for assigned programs, driving operational regulatory activities in partnership with the RA strategist. Lead GRST meetings, track key deliverables, and proactively manage risks and mitigation plans.
Drive timelines and deliverables related to submission documents. Track progress and review project(s) tasks to meet deadlines. Point of contact re: timelines and status of submissions / approvals / responses and commitments globally.
Lead the day-to-day operation of the Dossier Task Force/filing team and ensure compliance with dossier compilation and global submission processes.
Establish clear ownership for project tasks, ensure that team members have the tools needed. Communicate process and document standards to stakeholders.
Identify and communicate critical processes or issues in project(s) and develop solution strategies together with the regulatory lead and project team functional representatives and/or head of function, when relevant.
Responsible for the overall publishing activities for the assigned product. Establish good relationship with publishing vendor. Ensure timely, high quality dossier assembly and publishing in accordance with Submission Content Plan.