Alpha-9 Oncology, Inc.-posted about 1 month ago
Full-time • Mid Level
Boston, MA
Professional, Scientific, and Technical Services

Alpha-9 Oncology is seeking an accomplished Senior Manager/Associate Director, Regulatory Affairs to lead global regulatory strategy and operations across our growing radiopharmaceutical pipeline. In this role, you will advance early- and mid-stage programs by shaping regulatory strategy, ensuring compliance, and building the systems and processes needed to scale a global regulatory function. You will have the opportunity to take ownership of regulatory operations, manage submissions, interact with health authorities, and establish standards that will guide Alpha-9 for the future.

  • 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.
  • Bachelor's degree in Life Sciences, Pharmacy, or a related field required; advanced degree (Ph.D., Pharm.D., or equivalent) preferred.
  • 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.
  • Experience in radiopharmaceuticals, radioligand therapies (RLTs), or oncology is preferred.
  • competitive salary
  • bonus
  • equity
  • 20 vacation days
  • 5 sick days
  • a technology allowance
  • commuter reimbursement
  • generous retirement savings plans with employer matching
  • extended health benefits
  • paid holidays
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