Associate Director/Director, Regulatory Affairs

Marengo Therapeutics Inc • Cambridge, MA

5d • Onsite

About The Position

Marengo Therapeutics is a Phase 2 clinical-stage immuno-oncology company developing first-in-class immune activators designed to precisely stimulate and expand anti-tumor T cells to drive deep, durable anti-tumor immunity. The company has a rich pipeline of multi-specific therapeutics powered by three different platforms supported by advanced antibody discovery and immunology insights. The company’s lead STAR program is progressing in the clinic across multiple solid tumor indications.

Marengo’s scientific platform and development strategy are further validated through multiple strategic partnerships with large-cap global pharmaceutical companies, reflecting the industry’s confidence in the novelty and potential impact of Marengo’s approach.

Reporting to the Chief Development Officer, the Associate Director/Director, Regulatory Affairs will contribute to regulatory planning while taking an active role in ensuring high-quality execution of regulatory activities across Marengo’s immuno-oncology programs. The role involves supporting the development of regulatory approaches and then driving the operational steps required to deliver clear, timely, and well-organized submissions and interactions with global health authorities.

You will work closely with cross-functional teams to ensure regulatory requirements are understood, documentation is prepared to standard, and program milestones are met. This position is well-suited for a regulatory professional who enjoys pairing sound regulatory judgment with active involvement in day-to-day execution to keep programs moving forward efficiently.

The ideal candidate is an experienced self-starter with sharp organizational instincts who communicates with clarity and confidence — equally at ease presenting to senior leadership and engaging directly with regulators.

Requirements

• Bachelor’s degree in life sciences required; advanced degree (PhD, MD, PharmD, or MS) strongly preferred.
• 7+ years of biopharmaceutical or pharmaceutical industry experience in Regulatory Affairs, with at least 3 years in immuno-oncology preferred.
• In-depth knowledge of the biologics development process, regulatory requirements, and applicable regulations and guidance.
• Extensive hands-on experience with INDs/CTAs, NDAs/BLAs/MAAs, and product lifecycle management.
• Demonstrated track record of significant regulatory accomplishments, including IND/CTA submissions that have progressed through development to approval.
• Strong, established experience in direct interactions and communications with global regulatory authorities.
• Excellent writing, interpersonal, organizational, and presentation skills.
• Demonstrated experience with regulatory budgeting and resource planning.

Nice To Haves

• Breadth across all regulatory affairs domains: clinical research, CMC, regulatory operations, nonclinical requirements, and compliance.
• Experience with biologics products is required; immuno-oncology product experience strongly preferred.
• Proven ability to identify, analyze, and resolve complex regulatory issues with a pragmatic, solutions-oriented approach.
• Demonstrated experience assessing team needs and providing mentorship or supervision to junior regulatory staff.
• Global regulatory experience (U.S. FDA, EMA, and/or other major health authorities).

Responsibilities

• Support the development and execution of regulatory plans/strategies that enable IND progression, clinical trial initiation and maintenance, and preparation for later-stage submissions.
• Provide clear, practical regulatory guidance to clinical, CMC, nonclinical, and operations teams to ensure deliverables are aligned with current requirements and are prepared to the expected standard.
• Serve as a key point of contact for the U.S. FDA and other regulatory authorities, coordinating meeting logistics, submission timelines, and follow-up activities.
• Prepare, review, and manage regulatory submissions—including INDs/CTAs, amendments, safety updates, and components of marketing applications—to ensure completeness, accuracy, and timely delivery.
• Contribute to preparation for regulatory agency interactions by drafting and assembling briefing materials, supporting internal review cycles, and ensuring teams are well-prepared for discussions.
• Monitor relevant regulatory guidance and updates, communicating practical implications to program teams and ensuring operational processes remain aligned with current expectations.
• Coordinate work with external regulatory consultants and vendors to support submission preparation and other regulatory deliverables.
• Assist in identifying regulatory risks or gaps and support the planning and execution of actions needed to address them.
• Maintain accurate regulatory documentation and support efficient tracking, organization, and communication of submission components and agency interactions.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1-10 employees