Manager/Senior Manager, Regulatory Affairs

Damora Therapeutics; Massachusetts; On-site; USD 95,000 - 135,000; Full time

Job summary

Damora Therapeutics in Massachusetts is seeking a Manager/Senior Manager, Regulatory Affairs to drive key regulatory activities. This role involves supporting the timely submission and approval of regulatory submissions while managing cross-functional relationships.

The ideal candidate has 2-3 years of regulatory affairs experience in biotech or pharma, a Bachelor’s degree, and strong competency in global regulatory requirements. Join our team to help advance innovative treatments for hematologic disorders.

Qualifications

• 2-3 years of regulatory affairs experience in biotech or pharma.
• Experience supporting global regulatory submissions in US and ex-US regions.
• Strong competency in understanding global regulatory requirements.

Responsibilities

• Support timely submission and approval of regulatory submissions.
• Coordinate and prepare document packages for regulatory submissions.
• Manage cross-functional relationships with internal teams.

Skills

Regulatory affairs experience in biotech or pharma

Understanding of science and medicine

Cross-functional collaboration

Competency in global regulatory requirements

Education

Bachelor’s degree

Advanced degree (MS, PharmD, PhD)

Job description

Manager/Senior Manager, Regulatory Affairs

About Us

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.

This is a unique opportunity to join a science-driven company at a formative stage, where early clinical data will directly shape development strategy and drive long-term value. The right candidate will join a team with significant early- and late-stage development experience, with the goal of quickly moving through dose escalation/expansion into pivotal trials.

The Role

The Manager/Senior Manager, Regulatory Affairs drives key regulatory activities, working seamlessly across functions to translate scientific, clinical, and technical insights into high-quality regulatory submissions while supporting regulatory strategy across the organization. This individual serves as a regulatory representative on the study teams throughout the product lifecycle.

What You’ll Do

• Supports timely submission and approval of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA), amendments and future marketing applications, with support and guidance from senior regulatory management as needed.
• Coordinates and prepares document packages for regulatory submissions to ensure alignment and compliance with applicable regulations and guidelines.
• Manages relationships cross functionally with internal teams, including program teams, CMC, Clinical, Translational, Quality and external partners to execute routine regulatory activities.
• Coordinates external regulatory operations activities with outside partners (i.e. publisher, external consultants).
• Supports the preparation for regulatory authority interactions, meetings and inspections.
• Maintains and improves tracking and archival systems to ensure efficient and compliant operations for regulatory submission preparation and archival.
• Performs regulatory research to keep abreast of regulatory procedures, FDA/EMA/ICH guidance and policy trends and provides guidance to internal teams to ensure compliance.
• Partners closely with senior regulatory management to support regulatory strategy, long-range regulatory planning, and other regulatory duties for assigned program.

What You’ll Bring

• Bachelor’s degree and a solid understanding of science and medicine. Advanced degree (MS, PharmD, PhD) a plus.
• 2-3 years of regulatory affairs experience in biotech or pharma.
• Experience supporting global regulatory submissions in key regions such as US (FDA) and ex-US (EMA, PMDA etc).
• Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
• Able to work cross-functionally and in a fast-paced startup environment.

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.