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.

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.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
• Strong understanding of global (US and ex-US) pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Oversight of CROs in the management of ex-US CTAs/INDs towards clinical trial activations preferred.
• High attention to detail; ability to coordinate and prioritize assigned projects according to company goals.

Qualifications

• Excellent written and verbal communication skills along with an MD, Ph.D., Pharm D. or master's degree.
• Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
• At least 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.

Preferred Qualifications

• Experience supporting BLA/MAA preparation or review.
• Familiarity with global regulatory frameworks (EMA, MHRA, PMDA, CDE).
• Background in rare disease natural history studies or patient focused drug development.
• Experience in a fast-paced biotech environment with first in human or first in class programs.

Physical Demands

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. No specific work demands.