Senior Director, Compliance

Role Summary

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.

Responsibilities

• 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.
• Maintain compliance 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.
• 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, sponsorships, 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, as applicable, board or committee oversight regarding compliance risks, program effectiveness, investigations, remediation, and emerging trends.
• Lead compliance training and communications programs that enhance ethical decision-making, regulatory expectations, and employee accountability.
• Clearly communicate requirements, explain the rationale behind decisions and provide regular updates on relevant changes or developments.
• Support due diligence and oversight activities related to vendors, distributors, consultants, contract manufacturing organizations, clinical research organizations, and other third parties.
• Serve as a liaison for internal and external audits, regulatory inquiries, inspections, and compliance-related reviews, as appropriate.

Requirements

• Bachelor’s degree required, JD preferred.
• Minimum 7 years of compliance, legal, regulatory experience, including significant experience in the pharmaceutical or biotechnology industry.
• Comfortable operating in a growth-stage biotech environment with dynamic priorities, with proven ability to operate in a "hands-on" fast-paced environment.
• Experience supporting product launch activities preferred.
• Demonstrated knowledge of laws, regulations, guidance, and industry standards relevant to pharmaceutical operations, such as FDA requirements, clinical trial obligations, healthcare compliance obligations, privacy requirements, anti-bribery and anti-corruption laws, and industry codes of conduct.
• Experience developing and operationalizing compliance policies, procedures, monitoring plans, risk assessments, investigations, training, and corrective action processes.
• Familiarity with compliance program effectiveness frameworks preferred.
• Strong judgment, discretion, and ability to manage sensitive and confidential matters with professionalism and integrity.
• Proven ability to influence senior leaders, build cross-functional relationships, and provide pragmatic, risk-based guidance in a complex regulated environment.
• Excellent written and verbal communication skills, including the ability to present complex compliance topics clearly to business and executive audiences.