5+ years of experience in regulatory affairs, preferably within biologics or small molecules.
Proven track record in managing IND submissions and FDA interactions.
Strong understanding of lifecycle management and regulatory strategies.
Ability to work cross-functionally with clinical and CMC teams.
Experience in a fast-paced biotech environment is essential.
Responsibilities
Own and execute the global regulatory strategy for a late-stage immunology program.
Lead high-stakes engagements with FDA and other regulatory bodies.
Drive the preparation and submission of INDs and global filings.
Collaborate with clinical and CMC teams to shape development strategies.
Influence strategic decisions with leadership and functional teams.
Help establish and enhance regulatory infrastructure within the organization.
Benefits
Autonomy in decision-making and strategic influence.
Opportunity to shape regulatory processes in a growing biotech setting.
High visibility within the organization, offering direct impact on program success.
Collaboration with cross-disciplinary teams in clinical and CMC domains.
Full Job Description
We have an exciting opportunity for a high-impact Director of Regulatory Affairs to lead global strategy for a priority immunology program at a pivotal late-stage moment. This role owns regulatory direction toward registration, serving as the key voice in FDA interactions and driving INDs, lifecycle strategy, and global submissions.
With real autonomy and visibility, you'll shape cross-functional decisions, influence clinical and CMC strategy, and help build regulatory infrastructure in a fast-growing biotech environment. If you bring deep small-molecule expertise and thrive where strategy meets execution, this is a chance to make a meaningful impact on a program with real momentum.
Key highlights: • Own global regulatory strategy for a late-stage immunology program • Lead FDA engagement and high-stakes regulatory interactions • Drive submissions, lifecycle planning, and global filings • Partner cross-functionally across clinical, CMC, and leadership teams • High-visibility role with strong influence and autonomy • Opportunity to help shape regulatory infrastructure in a growing biotech
