Job Title

Role PurposeTo provide end-to-end legal leadership and advisory support across pharmaceutical operations, ensuring compliance with applicable laws, mitigating legal risk, and enabling business growth. The role covers regulatory compliance, contracts, litigation management, IP, corporate governance, and risk management in highly regulated domestic and international markets.Key ResponsibilitiesRegulatory & Compliance (Pharma-Specific)- Advise on compliance with drug laws, pharmaceutical regulations, pricing controls, and healthcare compliance frameworks. - Support regulatory submissions, inspections, audits, and interactions with authorities (e.g., DCGI, CDSCO, MOH, US FDA, EMA, WHO). - Monitor changes in pharmaceutical laws and advise business teams on compliance impact. - Ensure adherence to ethical marketing, anti-bribery, pharmacovigilance, and data integrity standards.Contracts & Commercial Legal Support- Draft, review, and negotiate complex commercial agreements including: - Contract manufacturing (CMO/CDMO) agreements - Distribution, agency, and export contracts - Licensing, technology transfer, and co-marketing agreements - Clinical trial and CRO agreements - NDAs, SLAs, and supply agreements - Support pricing, tender documentation, and government contracts where applicable.Intellectual Property (IP) Management- Oversee IP strategy including patents, trademarks, copyrights, and trade secrets. - Coordinate with external IP counsels for filings, oppositions, renewals, and litigation. - Support IP due diligence for in-licensing, out-licensing, and M&A activities.Litigation & Dispute Management- Manage and oversee litigation, arbitration, and regulatory disputes. - Coordinate with external law firms and legal advisors. - Handle matters related to product liability, contract disputes, labor law cases, and regulatory actions. - Develop legal strategies to minimize exposure and protect company interests.Corporate Governance & Risk Management- Advise the Board and senior management on corporate governance matters. - Ensure compliance with Companies Act, SEBI (if applicable), and internal policies. - Support M&A, joint ventures, and strategic transactions including legal due diligence. - Develop and implement legal risk management frameworks and internal controls.Policy Development & Training- Draft and update internal legal policies, SOPs, and compliance frameworks. - Conduct legal and compliance training for business, sales, regulatory, and manufacturing teams. - Promote a culture of compliance, ethics, and risk awareness.Key Stakeholders- Internal: MD/CEO, Board, R&D, Regulatory Affairs, Manufacturing, Sales & Marketing, Finance, HR - External: Regulatory Authorities, Law Firms, IP Attorneys, Auditors, Business PartnersQualifications & Experience- Bachelor’s or Master’s degree in Law (LLB / LLM) - Qualified lawyer with bar registration - Strong experience in pharma, life sciences, healthcare, or biotech - Proven exposure to regulatory compliance, contracts, and litigation - Experience with international markets and export regulations is an advantageSkills & Competencies- Deep understanding of pharmaceutical laws and regulatory frameworks - Strong contract negotiation and drafting skills - Strategic thinking with commercial orientation - Excellent communication and stakeholder management - High ethical standards and risk-management mindse