Jobs at Zydus Therapeutics Inc.

Lead operational execution and oversight of in-house and outsourced clinical trials (Phase I-III). Manage CRAs and CROs, drive start-up through close-out, ensure ICH-GCP compliance, RBM and SDV monitoring, TMF/eTMF completeness, inspection readiness, risk mitigation, and cross-functional collaboration. Provide coaching, governance, KPI tracking, and regulatory inspection support.

Lead national and federal payer account strategies to secure coverage and reimbursement for Zydus Therapeutics products. Build executive-level relationships with PBMs, payers, VA/DoD, and state agencies; develop account plans, negotiate contracts, coordinate cross-functional implementation, address coverage issues, and support commercial launch activities for rare/specialty oral therapies.

Manage all site monitoring activities (SQV, SIV, PMV, COV) per ICH/GCP; act as primary site contact, train site staff, ensure safety reporting, protocol compliance, IP and supply management, assist recruitment, oversee eTMF and documentation, escalate and remediate noncompliance.

Lead U.S. product labeling and promotional regulatory activities, ensure advertising and medical materials comply with FDA OPDP and labeling regulations, manage USPI lifecycle, run and optimize Medical & Legal Review processes and committees, prepare advisory requests and 2253 filings, and provide strategic regulatory guidance across cross-functional teams.

Lead and continuously improve the enterprise compliance program for a clinical-stage biotech. Advise senior leadership, design and implement risk-based policies, monitor and audit field and third-party activities, manage investigations and remediation, deliver training, support regulatory interactions, and ensure adherence to FDA, privacy, anti-corruption, and industry standards.

Lead market research and analytics to generate actionable insights for HCPs, patients, and payers in PBC. Drive customer segmentation, competitive intelligence, launch readiness, and cross-functional integration to inform brand strategy and commercial execution for Saroglitazar.