Senior Manager

Job Description: Senior Manager – Legal

Designation: Senior Manager – Legal

Department: Legal & Compliance

Location: Mumbai

Industry: Pharmaceuticals

Position Overview

The Senior Manager – Legal will lead and manage legal affairs for the organization, ensuring full compliance with statutory requirements, mitigating legal risks, and supporting critical business functions. This role demands deep knowledge of pharma regulations, contract law, litigation management, and intellectual property matters.

Key Responsibilities

1. Regulatory & Statutory Compliance

• Ensure compliance with all applicable laws and regulations governing the pharmaceutical industry, including Drugs & Cosmetics Act, DPCO, GMP, GCP, FDA/EMA guidelines (where applicable).
• Monitor regulatory updates and advise management on legal implications.
• Oversee company-wide compliance programs, SOP reviews, audits, and risk assessments.

2. Contract Management

• Draft, review, and negotiate a wide range of agreements:
• Manufacturing & supply agreements
• Licensing & distribution agreements
• Clinical trial agreements
• CDMOs/CMOs
• Vendor agreements
• R&D collaboration agreements
• Ensure contracts are aligned with business goals while protecting the organization from legal exposure.

3. Litigation & Dispute Management

• Manage and coordinate litigation with external counsel.
• Handle matters related to product liability, labour disputes, commercial claims, and IP infringement.
• Prepare legal strategies, responses, notices, and settlement recommendations.

4. Intellectual Property (IP)

• Support IP-related matters including patents, trademarks, copyrights, and trade secrets.
• Coordinate with patent attorneys for filings, oppositions, renewals, and IP strategy in alignment with R&D.

5. Advisory & Business Partnering

• Serve as a trusted advisor to senior leadership and cross-functional teams (R&D, QA/QC, Manufacturing, Sales & Marketing, HR).
• Provide actionable legal guidance on new projects, market expansions, corporate structuring, and commercial decisions.
• Conduct risk analysis and recommend solutions that balance compliance with business speed.

6. Policy, Governance & Documentation

• Develop and maintain internal legal policies and compliance frameworks.
• Ensure proper record management, document control, and contract repository.
• Support internal audits and due diligence for partnerships, M&A, and investments.

7. Training & Awareness

• Conduct training sessions for employees on legal topics such as compliance, contract awareness, IP hygiene, data privacy, anti-bribery, competition law, etc.

Required Qualifications & Experience

• LL.B./LL.M. from a recognized university.
• 10–15 years of experience in the pharmaceutical or life-sciences sector (mandatory).
• Strong understanding of pharma regulations, manufacturing laws, clinical research, and global regulatory frameworks.
• Demonstrated expertise in contract drafting, negotiation, compliance, and litigation.
• Experience collaborating with regulatory affairs, QA, production, R&D teams and Government Bodies.

Key Skills & Competencies

• Excellent command over contract law and pharma-related legal frameworks.
• Strong business acumen with ability to translate legal risks into business language.
• Drafting, negotiation, and communication skills.
• High integrity, sound judgement, and an ability to handle sensitive information.
• Strategic thinking with a hands-on execution approach.
• Ability to work under pressure and manage multiple priorities — the pharma world waits for nobody.

Preferred Attributes

• Experience in both corporate legal departments and law firms.
• Exposure to international regulatory environments (EU/US).
• Knowledge of data privacy (GDPR), competition law, and ESG compliance.

Job Types: Full-time, Permanent

Pay: ₹100, ₹125,000.00 per month

Application Question(s):

• Candidates should have more exposure related to R & D

Work Location: In person