Senior Director, Compliance

Zydus Therapeutics Inc.•Pennington, NJ

2d•$300,000 - $320,000•Onsite

About The Position

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.

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.

Nice To Haves

JD preferred.
Experience supporting product launch activities preferred.
Familiarity with compliance program effectiveness frameworks preferred.

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.