Director of Labeling & Promotional Review

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist.

Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA).

As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. Zydus Therapeutics, Inc. is seeking a candidate for the role of Director of Regulatory Labeling, Advertising, and Promotion who will oversee U.S. product labeling and promotional regulatory activities across the company’s portfolio. This position provides strategic/operational leadership to ensure promotional materials and labeling are scientifically accurate, FDA-compliant (OPDP), and aligned with corporate objectives.

RESPONSIBILITIES:

• Ensure that advertising, and promotional materials meet applicable advertising and promotion regulations.  Ensure that medical affairs materials meet applicable regulations.
• Oversee the development, maintenance, and lifecycle management of core labeling documents, including USPI and patient information leaflets.
• Partner with Supply Chain, Commercial, Medical, Legal, Compliance, and Regulatory Operations teams to effectively and efficiently build regulatory compliance into product labeling distribution, marketing and medical strategies and execution. The Regulatory Operations team is based in India.
• As the regulatory lead on the Promotional and the Medical Review Committees, design and optimize Medical & Legal Review (MLR) processes for Promotional and for Medical Affairs pieces, SOPs, and Review Committee operations to strengthen compliance and efficiency.
• Be the point of contact with OPDP, preparing advisory requests, 2253 filings, and engaging in enforcement risk management.
• Provide strategic regulatory input on claims, safety information, and labeling changes, assessing their impact on promotional materials and overall communication strategy.
• Train internal teams on FDA enforcement trends, guidance updates, and best practices.