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Alpha-9 Oncology · 1 day ago

Senior Manager/Associate Director, Regulatory Affairs

Boston, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$148K/yr - $200K/yr

5+ years exp

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. They are seeking a Senior Manager/Associate Director, Regulatory Affairs to lead global regulatory strategy and operations, manage submissions, and interact with health authorities to ensure compliance and support development milestones.

BiotechnologyMedicalProduct Research

Responsibilities

Lead the development and execution of regulatory strategies to support development milestones and interactions with health authorities

Prepare, submit, and maintain global regulatory filings including INDs, CTAs, amendments, annual reports, and safety updates

Design and implement submission workflows, document control processes, and systems to ensure accuracy, consistency, and inspection readiness

Support or lead the preparation of briefing materials and participate in meetings with regulatory agencies

Track and manage agency queries and commitments, coordinating responses and update across functional teams

Collaborate closely with Clinical Development, CMC, and Quality teams to ensure submissions and strategies are aligned with program objectives

Monitor evolving regulations and guidance, keeping teams informed and driving continuous process improvements

Qualification

Regulatory strategy developmentGlobal submission managementRegulatory submissions INDsRegulatory submissions CTAsRIM/EDMS tools (Veeva)Early-phase drug developmentProject managementExperience in oncologyCommunication skillsCollaboration skills

Required

Bachelor's degree in Life Sciences, Pharmacy, or a related field required

Minimum of 5+ years of experience in regulatory affairs within biotechnology or pharmaceutical development, with a focus on global submission management

Proven experience managing global regulatory submissions (INDs, CTAs, amendments, annual reports) and interfacing with global health authorities such as FDA, EMA, TGA, and Health Canada

Skilled in implementing and managing regulatory processes and electronic submissions using RIM/EDMS tools (e.g., Veeva)

Solid understanding of early-phase drug development, including CMC, nonclinical, and clinical components

Demonstrated experience authoring or reviewing regulatory submission documents and contributing to regulatory strategy development

Strong project management and communication skills, with the ability to collaborate effectively across cross-functional teams in a fast-paced environment