AGM / DGM - Legal

Position Summary:

The AGM / DGM of Legal & Compliance will lead and manage all legal, regulatory, governance, risk management, and compliance functions across Lambda Clinical Research and Biosimilars businesses. The role will ensure compliance with applicable laws, regulations, contracts, ethics standards, corporate governance requirements, and industry-specific guidelines related to Clinical Research, Contract Research Organization (CRO) operations, Biosimilars, Pharmaceuticals, and Healthcare services.

The incumbent will act as a strategic business partner to senior leadership while protecting the organization's legal interests, minimizing risks, and ensuring robust compliance frameworks across India and international operations.

Key Responsibilities:

1. Contract Management

Review, draft, negotiate, execute, and manage a wide range of commercial and legal agreements, including Clinical Trial Agreements (CTAs), Master Service Agreements (MSAs), Non-Disclosure Agreements (NDAs), Vendor Agreements, Investigator Agreements, CRO Service Agreements, Licensing Agreements, Technology Transfer Agreements, and other contracts required to support the operations of Lambda and its associated group companies. Ensure contractual compliance, mitigate legal risks, safeguard organizational interests, and provide timely legal support to business stakeholders throughout the contract lifecycle.

2. Clinical Research Compliance

Ensure compliance with ICH-GCP Guidelines, CDSCO regulations, Ethics Committee regulations, Drug and Cosmetics Act requirements, Sponsor obligations, International Clinical Trial regulations

3. Provide legal guidance on:

Subject compensation, Informed consent, Data privacy, Clinical trial documentation, Audit observations, Inspection findings

4. Biosimilar & Pharmaceutical Compliance

Support Biosimilar development, manufacturing, licensing, and commercialization activities. Review regulatory submissions and partner agreements.

5. Litigation Management

Commercial disputes, Employment matters, Regulatory notices, Arbitration proceedings, Recovery matters, Intellectual property disputes, Coordinate with external advocates and legal consultants.

Educational Qualification

• Bachelors degree in law (LLB) / LLM

Experience

• 10-15 years of post-qualification experience.
• Minimum 2 years in leadership role.

Preferred Industry Experience

• Contract Research Organization (CRO), Clinical Research, Pharmaceuticals, Biotechnology, Biosimilars, Healthcare Services

Compliance

• Compliance Management Systems
• Risk Management
• Internal Investigations
• Governance Frameworks