Teams at Zydus Therapeutics Inc.

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.

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.