Advocate

We are seeking an experienced Corporate Legal Advocate to manage and support the legal and compliance requirements of our pharmaceutical business. The role involves handling corporate legal matters, regulatory compliance, contracts, and coordination of litigation to ensure the company operates in accordance with applicable laws and industry regulations.

Key Responsibilities-

1. Contract Drafting & Management-

· Draft, review, negotiate, and manage a broad spectrum of commercial and regulatory contracts, including agreements with contract manufacturers, transporters, CFAs, warehouses, vendors, distributors, research partners, and government entities (NDAs, SLAs, MoUs, licensing, technology transfer, and partnership agreements), ensuring alignment with pharmaceutical regulatory requirements and protection of company interests.

· Maintain and administer a centralized contract repository with systematic tracking of renewals, amendments, expiries, and compliance obligations.

· Ensure end-to-end compliance with the Drugs & Cosmetics Act, 1940 and Rules, 1945, including applicable GMP, GDP, and regulatory conditions.

· Ensure strict adherence to the NDPS Act, 1985 and NDPS Rules, 1985 for handling, storage, manufacture, transport, sale, and record-keeping of narcotic and psychotropic substances.

· Monitor and manage regulatory compliance and inspections involving State FDA authorities, CDSCO, DCGI, and the Narcotics Control Bureau (NCB), including audit preparedness and post-inspection responses.

· Manage pharmaceutical and NDPS-related licenses, quotas, permits, and statutory filings, including Forms 3, 10, 25, 28, J, K, and other regulatory approvals, ensuring timely renewals and regulatory continuity.

· Embed NDPS- and Pharma-specific contractual safeguards, including clauses on regulatory compliance, Pharmacovigilance obligations, traceability, audit rights, data integrity, recall mechanisms, indemnities, and risk allocation.

· Review and negotiate distribution, CFA, and logistics agreements with enhanced focus on GDP compliance, NDPS controls, product security, reporting obligations, and liability management.

· Draft, review, and respond to correspondence, notices, and queries from regulatory and government authorities, including GST, Income Tax, Intellectual Property offices, drug regulators, and other statutory bodies, ensuring accurate, timely, and compliant submissions.

· Handle litigation, regulatory actions, and enforcement matters, including drafting and responding to show-cause notices, coordinating with external counsel, preparing legal submissions, and representing company interests before drug regulators, NCB, tribunals, and courts.

· Support internal compliance frameworks through legal advisory on SOPs, audits, risk assessments, and regulatory change management within a highly regulated pharmaceutical environment.

2. Narcotics Control & Documentation

· Oversee procurement, storage, manufacture, sale, distribution, and disposal of narcotic medicines.

· Ensure maintenance of mandatory NDPS registers, batch-wise records, and audit trails. · Review SOPs for handling, transportation, and destruction of narcotic drugs.

· Coordinate with NCB, State Excise, and Drug Inspectors during inspections.

· Ensure purchase quantities align with approved NDPS quotas and authorizations.

3. Transportation, Logistics & Traceability

· Ensure legal compliance for movement of scheduled & narcotic drugs (inter-state & intra-state).

· Vet transporters for NDPS movement permissions and GPS/lock requirements (where applicable).

· Review SOPs for e-way bills, consignment notes, seals, and handover protocols.

4. Warehousing, Storage, Inventory Control, Transportation, Logistics & Traceability

· Align with SCM & QA on secure storage, access controls, segregation, and stock reconciliation.

· Ensure compliance with NDPS storage norms, lock-and-key systems, and authorized personnel lists.

· Review discrepancies, shortages, or excess stock from a legal risk perspective.

· Identify legal risks in single-vendor dependency, emergency sourcing, stock transfers, and outsourcing.

· Ensure returns, recalls, expiries, and destruction follow legal and NDPS procedures.

· Advise SCM on reverse logistics risks. 5. Drafting Policy & Internal Controls

· Draft and update internal policies (code of conduct, POSH, whistleblower, data privacy).

· Ensure policy communication and implementation across organization.

· Provide legal guidance to QA, QC, teams.

· Review SOPs for GMP, GDP, and NDPS compliance.

· Support new product launches involving scheduled and narcotic drugs.

· Product recall & destruction

· Conduct internal compliance training on NDPS and pharma laws.

5. Incident Management & Regulatory Response

· Lead legal response to seizures, shortages, theft, loss, or diversion risks.

· Coordinate with SCM, QA/QC, Security, and Authorities during inspections or raids.

· Draft Incident reporting & deviations, corrective actions, and preventive measures.

· Provide legal advice to sales, marketing, finance, HR, and operations.

6. Litigation, Dispute Management, Regulatory Liaison & Government/Authorities Interface

· Handle show-cause notices, seizures, suspension/cancellation of licenses, and prosecutions, claims, and disputes (commercial, consumer, regulatory).

· Coordinate with external counsels and manage commercial, consumer, regulatory litigation strategy & NDPS related cases.

· Liaise with NCB, CDSCO, State Drug Controllers, Excise & Customs authorities.

· Manage responses to inspections, audits, and information requests.

· Track and report periodic case progress, costs, and outcomes.

7. Risk Management & Due Diligence

· Conduct legal due diligence for acquisitions, in-licensing, out-licensing, and contract manufacturing.

· Assess NDPS risk exposure in business expansion, exports, and institutional sales.

· Identify legal risks in transactions, deals, and operations and recommend risk mitigation measures.

8. Documentation & Record Management

· Maintain organized legal records, contracts, and case files.

· Ensure data confidentiality and document control.

· Manage legal budgets and optimize external legal spend.

· Appoint and evaluate external counsels with NDPS expertise.

9. Ethics, Confidentiality & Zero Tolerance

· Ensure ethical handling of controlled substances.

· Maintain strict confidentiality and zero tolerance for diversion or misuse.

· Support whistleblower and vigilance mechanisms.

· Maintain strict confidentiality of company information.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

Benefits:

• Provident Fund

Work Location: In person