Senior Director, Compliance

Description

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. 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 dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation, orphan drug designation and priority review designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Primary Biliary Cholangitis is a rare, chronic autoimmune liver disease primarily affecting middle-aged women, characterized by the progressive destruction of the bile ducts that can lead to irreversible liver damage if left untreated.

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.

The opportunity to empower people with the freedom to live healthier and more fulfilling lives is what makes a career with Zydus Therapeutics so rewarding. Our team is collaborative, innovative and adaptable. We are action-oriented and strive for excellence in all we do, all underpinned by respect, trust and integrity. We offer a wide variety of competitive benefits, services and support programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives

If you are passionate about helping bring potential life-changing discoveries to patients, then you share our mission.

Zydus Therapeutics is seeking a Senior Director of Compliance. Reporting to the General Counsel & Chief Compliance Officer, with a dotted line to the Chief Operating Officer, the Senior Director of Compliance will be responsible for leading and continuously improving the company’s compliance program. This role ensures that business activities comply with applicable laws, regulations, industry standards, and internal policies, including requirements related to FDA-regulated activities, promotional practices, privacy, anti-kickback and anti-corruption controls, third-party oversight, investigations, auditing and monitoring of field sales force and developing policies and training.

The Senior Director will serve as a strategic advisor to senior leadership and partner closely with all business functions to promote a culture of ethics, accountability, and compliance.

• · Partner with leaders across Legal, Commercial, Medical and Clinical Development to Design, implement, maintain, and enhance a risk-based compliance program aligned with applicable pharmaceutical laws, regulations, guidance, industry codes, and company policies.
• · Monitor regulatory and enforcement developments affecting pharmaceutical operations and translate changes into development of practical policies, standard operating procedures, codes of conduct, training, and business guidance.
• · Lead enterprise compliance risk assessments, identify areas of vulnerability, and develop corrective and preventive action plans in partnership with business owners.
• · Oversee and execute compliance monitoring, auditing, testing, and reporting activities (including sunshine act reporting), for internal team, field-based team and contracted third-party team to assess adherence to policies, procedures, and regulatory requirements.
• · Provide compliance guidance on medical and scientific exchange, payer engagement strategies, drug safety, market research, healthcare professional interactions, grants, donations, sponsor ships, patient support programs, third-party engagements, and other regulated activities.
• · Manage internal compliance investigations, including intake, triage, documentation, root-cause analysis, corrective actions, and escalation to appropriate stakeholders.
• · Prepare periodic reports for executive leadership and,…