Director, Global Regulatory Affairs

About the role

The Director, Global Regulatory Affairs leads Protara’s ex-US regulatory strategy and operational execution for Protara’s clinical studies in oncology, cell and gene therapy, and rare diseases. The leader will possess ex-US global submissions experience and manage study specific regulatory submissions and will have country level experience either from the sponsor or CRO side managing global studies. The Director, Global Regulatory Affairs will provide leadership on ex-US regulatory activities for Protara’s product portfolio, and responsibility will focus on clinical study applications and provide regulatory leadership on the project teams in this area. The candidate will lead and/or supervise IND/CTA submissions including but not limited to South America, APAC, EU, etc.

Responsibilities

• Provide interpretation of regulatory authorities' feedback, policies, and guidelines.
• Lead the development of study level regulatory strategic plans either directly in conjunction with program and study teams. Own the preparation of major clinical submissions required for regulatory approval.
• Work with program and study teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
• Responsible for quality and timeliness of IND/CTA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
• Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with program and study team timelines.
• Provide interpersonal support and lead personnel.

Qualifications

• To be considered, you must possess excellent written and verbal communication skills along with an MD, Ph.D., Pharm D. or master's degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
• 8–12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Demonstrated success interacting with the FDA, EMA and other global health authorities for oncology, cell and gene therapy, or rare disease programs.
• Hands‑on experience leading IND submissions and regulatory meetings.
• Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
• Excellent written and verbal communication skills, with the ability to translate complex science into clear regulatory positions.