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Job Description
Roles & Responsibilities
Role Purpose
To 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 Responsibilities
Regulatory & 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 Partners
Qualifications & 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 advantage
Desired Candidate Profile
Skills & 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
Employment Type
- Full Time
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Lawyers
- Legal Advisors
Keywords
- Legal
- Law
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TASC Labour Services L.L.C
As TASC Outsourcing, we delivered innovative, effective hiring solutions to businesses of all types and sizes. Today, we’ve grown into one of the region’s leading recruitment, staffing and HR service providers. Working in collaboration with some of the region’s biggest names (and some of its newest). And with a fresh new look to help us stand out in the crowd.
Read MoreManjula Arkeri Arkeri - VP - Recruitments
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