Your Impact

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.

How You'll Contribute

• 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.

The Skills You Bring

• 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.

What's in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.