Job Type
Full-time
Description
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. 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.
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.
• 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, 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
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.
TRAVEL REQUIREMENTS
The position will require domestic travel (up to 25%)
Work Environment
This is an office-based position, located in our office in Pennington, NJ.
