Position Summary

Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing strategic and operational leadership supporting late-stage clinical development through regulatory submission, approval, and product launch. This individual will serve as a key member of the project team and provide regulatory support for strategy implementation across the functions with a primary focus on FDA interactions and U.S. registration.

The ideal candidate brings deep expertise in rare disease regulatory pathways and biologics development, including experience in endocrinology, metabolic, and oncology programs. This leader will have a strong understanding of CMC considerations for biologics and experience navigating complex regulatory requirements associated with BLA submissions. The candidate will have experience in late-stage approval activities and support for commercial launch.

This is a hands-on leadership role requiring both strategic vision and execution in a lean, fast-paced environment.

Key Responsibilities

• Develop and execute regulatory strategies for biologic programs in rare disease indications, including endocrinology, metabolic, and oncology consistent with corporate and project objectives and gain consensus across the organization with respect to those strategies.

• Key contributor in agency regulatory interactions, including the preparation of clinical stage (IND, CTA) and marketing (BLA, MAA) applications, and formal meetings.
• Pursue expedited pathways (e.g., Orphan Drug Designation, Fast Track, Breakthrough Therapy, RMAT where applicable).
• Provide regulatory guidance across Clinical Development, CMC, Nonclinical, and Commercial functions.
• Represent regulatory in project team discussions and present issues and solutions accordingly.
• Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project teams and Company management.
• Ensure alignment of regulatory strategy with clinical development plans, applying special considerations for small patient populations and innovative trial designs.
• Identify and mitigate regulatory risks, including those specific to biologics.
• Monitor for emerging trends in regulatory policies, regulations, and guidelines; provide analysis and applicability to Rezolute programs and activities.
• Support business development, due diligence, and investor communications with regulatory insights.
• Ensure compliance with applicable laws and regulations related to our product development and marketing activities.

Qualifications

• BS/MS degree required; advanced degree desirable
• 15+ years of regulatory affairs experience in the biopharmaceutical industry.
• Significant experience with biologics development, including contribution to successful BLA submissions and approvals.
• Must have experience with regulatory activities for commercial launch activities (eg MLR, PRC)
• Demonstrated technical knowledge associated with successful submissions to regulatory agencies
• Knowledge of Clinical, Nonclinical and CMC regulatory issues, quality systems and processes.
• Knowledge of and success with regulatory designations (e.g. orphan, Fast-track. Breakthrough Therapy Designation) and ex-US equivalents.
• Experience with forming global strategy and execution of regulatory efforts with US, EU and other ex-US health authorities
• Strong experience in rare disease drug development, including endocrinology, metabolic disorders, and/or oncology.
• Demonstrated success in health authority interactions.
• Deep understanding of CMC requirements for biologics, including manufacturing, comparability and lifecycle management.
• Working knowledge of global regulatory requirements (EMA, PMDA) is a plus.
• Proven ability to operate effectively in small to mid-sized biotech environments in a hands-on capacity.
• Experience managing regulatory CROs, consultants and publishers.
• Experience managing personnel and developing goals in line with corporate objectives within the regulatory function.
• Demonstrated ability to translate strategy into action; excellent analytical skills and ability to communicate complex issues in a simple way and orchestrate plans to resolve issues and mitigate risks.
• Demonstrated conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
• Strong leadership, communication, and cross-functional collaboration skills.

Key Competencies

• Strategic leadership in biologics and rare disease regulatory pathways
• Deep expertise in regulatory strategy and execution
• Strong grasp of biologics CMC and regulatory risk management
• Influential cross-functional leadership
• Agile, execution-focused mindset

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement