Senior Manager/Associate Director, Regulatory Affairs

We are seeking a Senior Manager/Associate Director, Regulatory Affairs to lead global regulatory strategy and operations across our growing radiopharmaceutical pipeline. The ideal candidate will have a strong background in regulatory affairs and experience managing global regulatory submissions, as well as the ability to collaborate effectively across cross-functional teams in a fast-paced environment.

Requirements

• 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.

Benefits

• Competitive salary
• Bonus
• Equity
• 20 vacation days
• 5 sick days
• Technology allowance
• Commuter reimbursement
• Generous retirement savings plans with employer matching
• Extended health benefits
• Paid holidays, tailored to local standards in each region