Astria Therapeutics, Inc.
Associate Director, Regulatory Affairs
Astria Therapeutics, Inc., Boston, Massachusetts, us, 02298
Overview
Associate Director, Regulatory Affairs
at
Astria Therapeutics, Inc. Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
This position is ideal for a global Regulatory Affairs leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. The role involves shaping and executing global regulatory strategies across development stages with a strong emphasis on cross-functional collaboration, strategic influence, and operational excellence.
Responsibilities
Serve as the regulatory lead on cross-functional development teams, providing strategic input and operational leadership across CMC, nonclinical, clinical, and commercial functions.
Develop and execute global regulatory strategies for biologics, including INDs, CTAs, IMPDs, and MAAs, ensuring alignment with corporate objectives and timelines.
Represent Regulatory Affairs in internal governance and external partner meetings with confidence, influence, and professionalism.
Lead the planning, preparation, and review of regulatory submissions in eCTD format, including briefing documents, safety reports, and annual updates.
Interpret and communicate evolving global regulatory requirements to internal stakeholders and ensure compliance across programs.
Oversee regulatory vendor relationships, including publishing, intelligence, and RIMS providers.
Contribute to the development and refinement of regulatory SOPs, best practices, and internal systems to support a scalable regulatory infrastructure.
Monitor and disseminate global regulatory intelligence and assess its impact on development programs.
Support regulatory inspection readiness and contribute to health authority interactions and meeting preparations.
Mentor junior regulatory staff and foster a culture of accountability, collaboration, and continuous improvement.
Qualifications
Bachelor’s degree in life sciences or related field required; advanced degree preferred.
Minimum 5 years of regulatory affairs experience in the biopharmaceutical industry, with a strong track record of global submissions and agency interactions.
Demonstrated experience with biologics and regulatory requirements across FDA, EMA, and other major health authorities.
Proven ability to lead cross-functional teams and influence without authority.
Excellent written and verbal communication skills, including the ability to tailor messaging to diverse audiences.
Highly organized, self-directed, and capable of managing multiple priorities in a dynamic environment.
Experience with regulatory systems (e.g., RIMS) and electronic publishing tools is a plus.
Astria’s Commitment At Astria, we are committed to building a team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patients-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote inclusion and belonging throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions. At Astria, people are our greatest asset, and by fostering an inclusive environment, we all shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
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Associate Director, Regulatory Affairs
at
Astria Therapeutics, Inc. Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
This position is ideal for a global Regulatory Affairs leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. The role involves shaping and executing global regulatory strategies across development stages with a strong emphasis on cross-functional collaboration, strategic influence, and operational excellence.
Responsibilities
Serve as the regulatory lead on cross-functional development teams, providing strategic input and operational leadership across CMC, nonclinical, clinical, and commercial functions.
Develop and execute global regulatory strategies for biologics, including INDs, CTAs, IMPDs, and MAAs, ensuring alignment with corporate objectives and timelines.
Represent Regulatory Affairs in internal governance and external partner meetings with confidence, influence, and professionalism.
Lead the planning, preparation, and review of regulatory submissions in eCTD format, including briefing documents, safety reports, and annual updates.
Interpret and communicate evolving global regulatory requirements to internal stakeholders and ensure compliance across programs.
Oversee regulatory vendor relationships, including publishing, intelligence, and RIMS providers.
Contribute to the development and refinement of regulatory SOPs, best practices, and internal systems to support a scalable regulatory infrastructure.
Monitor and disseminate global regulatory intelligence and assess its impact on development programs.
Support regulatory inspection readiness and contribute to health authority interactions and meeting preparations.
Mentor junior regulatory staff and foster a culture of accountability, collaboration, and continuous improvement.
Qualifications
Bachelor’s degree in life sciences or related field required; advanced degree preferred.
Minimum 5 years of regulatory affairs experience in the biopharmaceutical industry, with a strong track record of global submissions and agency interactions.
Demonstrated experience with biologics and regulatory requirements across FDA, EMA, and other major health authorities.
Proven ability to lead cross-functional teams and influence without authority.
Excellent written and verbal communication skills, including the ability to tailor messaging to diverse audiences.
Highly organized, self-directed, and capable of managing multiple priorities in a dynamic environment.
Experience with regulatory systems (e.g., RIMS) and electronic publishing tools is a plus.
Astria’s Commitment At Astria, we are committed to building a team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patients-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote inclusion and belonging throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions. At Astria, people are our greatest asset, and by fostering an inclusive environment, we all shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr