SENIOR COMMERCIAL COUNSEL

ROLE SUMMARY

Reporting to the General Counsel with a dotted line to the Chief Operating Officer, the Senior Commercial Counsel will be responsible for providing legal strategy and oversight for Zydus Therapeutics’ product pipeline—from late-stage development through launch and commercialization. They act as a strategic business partner, ensuring that marketing and scientific communications comply with complex healthcare laws while protecting the company's brand and intellectual property. Counsel will be embedded as a core team member, serving as a strategic legal advisor to multiple internal stakeholders including commercial, medical affairs, regulatory and clinical development. Counsel will advise the team based on their deep understanding of both the complex laws and regulations as well as business and strategic objectives related to the development and commercialization of specialty bio-pharmaceutical products. The Counsel will be pivotal to the success of the Company as the organization transitions into a commercial-stage biopharmaceutical organization.

RESPONSIBILITIES

• Provides day-to-day strategic and business-focused legal and risk counseling for saroglitazar and the emerging Zydus Therapeutics pipeline, from development through launch & commercialization, including advising on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, payer engagement strategies, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
• Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning.
• Reviews and approves all branded and non-branded materials, including advertising, social media and medical congress presentations. This is typically done through participation in a cross functional Medical, Legal, and Regulatory committee.
• Negotiates, drafts, and reviews market access and customer-facing contracts including distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements.
• Conducts risk assessments for organization and offers practical solutions that balance legal risk with corporate objectives.
• Provides advice and guidance on all relevant federal and state healthcare laws, including the Federal Food, Drug, and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and HIPAA/data privacy.
• Drafts and negotiate master services agreements, quality agreements, payer contracts, clinical trial agreements, and vendor contracts for global studies.
• Provides additional legal support on various matters to the broader Regulatory and Legal team.
• Collaborates with cross functional partners including commercial, medical affairs, regulatory and clinical development to sustain a culture of compliance and integrity.

QUALIFICATIONS

• JD with excellent law school credentials and admission to a state bar in any jurisdiction, with NJ preferred.
• Have at least 5 years of legal experience at a nationally recognized law practice in the area of pharmaceutical and healthcare law or as an in-house attorney at a biotech/pharmaceutical company.
• Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred.
• Comfortable operating in a growth-stage biotech environment with dynamic priorities, with proven ability to operate in a "hands-on" fast-paced environment.

PAY

Competitive salary and benefits package.

SCHEDULE

Full-time, Monday through Friday, with some flexibility.