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Senior Director, Global Regulatory Affairs
Senior Director, Global Regulatory AffairsAstria Therapeutics, Inc. • Boston, MA, United States
Senior Director, Global Regulatory Affairs

Senior Director, Global Regulatory Affairs

Astria Therapeutics, Inc. • Boston, MA, United States
30+ days ago
Job type
  • Full-time
Job description

Position Overview :

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.

We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs to join our growing team at Astria Therapeutics, a dynamic biotechnology company advancing innovative therapies. The successful candidate will play a pivotal role in developing and executing global regulatory strategies, guiding programs from early development through marketing applications, and contributing to labeling and product lifecycle management. This position requires strong leadership, technical regulatory expertise, and the ability to influence and collaborate cross-functionally and at the executive level.

This individual will serve as a strategic partner to the Vice President of Regulatory Affairs, manage direct reports, and drive efficient planning, execution, and regulatory decision-making to meet corporate objectives. The ideal candidate will thrive in a fast-paced, small company environment, bringing a balance of agility, rigor, and strategic foresight.

Responsibilities :

  • Regulatory Strategy & Leadership

Design and lead implementation of global regulatory strategies across development programs.

  • Provide strategic regulatory guidance on cross-functional sub-teams (e.g., Product, Clinical, CMC).
  • Proactively identify and mitigate regulatory risks to ensure alignment with business objectives.
  • Regulatory Submissions & Health Authority Interactions

    • Lead the planning, preparation, and execution of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses.

  • Represent the company in meetings with FDA and global health authorities; drive briefing book development, lead rehearsals, and moderate live meetings.
  • Partner with internal teams and external vendors to ensure quality, timely, and compliant regulatory submissions.
  • Team & Program Leadership

    • Provide people management, coaching, and development for direct reports, enabling growth and success.

  • Drive team accountability for regulatory milestones and timelines; escalate and resolve critical path issues.
  • Actively manage interdependencies across programs to optimize regulatory planning and resource allocation.
  • Labeling, Compliance & Lifecycle Management

    • Contribute to target product labeling creation and regulatory labeling negotiations.

  • Oversee core prescribing information development and product maintenance submissions.
  • Ensure regulatory compliance of promotional and corporate materials in alignment with regulatory expectations.
  • Cross-functional Engagement & Vendor Management

    • Collaborate with external partners (CROs, regulatory consultants, and submission vendors) to support program needs.

  • Participate in due diligence activities for licensing, acquisitions, and other business development efforts.

    • Qualifications :

  • Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, or equivalent) preferred.
  • 10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with demonstrated experience across early to late-stage development and marketing applications.
  • Experience leading or participating in successful FDA and global health authority submissions and meetings.
  • Strong working knowledge of CTD / eCTD structure and global regulatory requirements.
  • Demonstrated ability to manage both strategic and operational aspects of regulatory activities.
  • People management experience required, with a demonstrated ability to lead and mentor others.
  • Experience operating in a small or start-up biotech environment, with a hands-on and collaborative approach.
  • Strong leadership, interpersonal, and communication skills, with ability to influence across functions and levels.
  • Regulatory Information System familiarity and experience developing phase-appropriate SOPs 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.

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    Director Regulatory • Boston, MA, United States