Director, Global Regulatory Affairs

Company Overview

Protara Therapeutics is a clinical‑stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. The portfolio includes TARA‑002, an investigational cell‑based therapy for non‑muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs), and IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support.

The Director, Global Regulatory Affairs leads Protara’s ex‑US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases. The role requires ex‑US global submissions experience, management of IND/CTA submissions, and country‑level experience either from the sponsor or CRO side.

• Provide interpretation of regulatory authorities’ feedback, policies, and guidelines.
• Lead the development of study‑level regulatory strategic plans 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 and ensure attainment of governmental approvals.
• Ensure quality and timeliness of IND/CTA submissions and interact with other functions and partners for document preparation and review.
• Plan, prioritize, supervise, and/or conduct activities in collaboration with leads from other areas, ensuring compliance with regulations and timelines.
• Provide interpersonal support and lead personnel.
• Demonstrate critical thinking, leadership, negotiation, and project management skills on drug development project teams.
• Possess strong understanding of global (US and ex‑US) pharmaceutical guidance, regulations, drug development processes, and industry standard practices.
• Oversee CROs in the management of ex‑US CTAs/INDs toward clinical trial activations (preferred).
• Maintain high attention to detail and ability to coordinate and prioritize projects according to company goals.
• Communicate effectively both in writing and verbally.

• MD, Ph.D., PharmD, or master’s degree with a minimum of 10 years of pharmaceutical industry experience, including at least 7 years 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.

• 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.

• Proficient in MS Office Suite.

• Strong interpersonal skills and ability to build relationships.
• Excellent written and oral communication, presentation skills, and ability to prioritize and multi‑task.
• Excellent organizational skills and attention to detail.
• Ability to handle highly confidential information.
• Proficiency in data mining and data extraction.
• Experience presenting to senior level management.
• Ability to work independently and collaboratively.
• Strong analytical and problem‑solving abilities.

• Minimal travel; average travel 5‑10% with variation based on business imperatives.

• No specific work demands noted.

Salary range: $228,000 – $233,000 based on experience. Benefits include incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.

Protara is an Equal Opportunity Employer committed to recruiting, hiring, training, and promoting without regard to race, color, creed, religion, national origin, citizenship status, age, sex, gender identity or expression, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any other characteristic protected by applicable law.