Director, Global Regulatory Affairs

🕒 April 14

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Protara Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Protara Therapeutics is a biopharmaceutical company dedicated to developing transformative therapies for patients with rare diseases and significant unmet medical needs. The company's lead investigational product, TARA-002, is a cell therapy designed for the treatment of non-muscle invasive bladder cancer and lymphatic malformations, and has received Rare Pediatric Disease Designation from the FDA. Additionally, Protara is working on IV Choline Chloride, an innovative therapy for patients requiring parenteral support who are deficient in choline.

📋 Description

• Lead Protara’s ex-US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases. • Provide interpretation of regulatory authorities’ feedback, policies, and guidelines. • Lead the development of study level regulatory strategic plans. • Own the preparation of major clinical submissions required for regulatory approval. • Work with program and study teams to resolve complex project issues. • Ensure compliance with regulations and program timelines. • Provide interpersonal support and lead personnel. • Critical thinking, leadership, assertiveness, negotiation and project management skills. • Oversight of CROs in the management of ex-US CTAs/INDs towards clinical trial activations.

🎯 Requirements

• Excellent written and verbal communication skills along with an MD, Ph.D., or Pharm D. degree. • 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. • Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships. • Proficiency in MS Office Suite, with advanced skills in Excel.

🏖️ Benefits

• Competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits. • Friendly, open, and fun team-oriented culture that values unique & diverse perspectives. • Company-wide dedication to profoundly impacting patients’ lives. • Amazing culture whereby our core values and behaviors are shared cross-functionally. • Flexible working hours/schedule. • Generous Paid Holidays and Unlimited PTO.