Sr. Manager / AGM - Corporate Regulatory Affairs (Drug Liaison)

Sr. Manager / AGM Drug Liaison

Department: Corporate Regulatory Affairs

Location: Panchkula / Dappar

Reporting To: Head – Regulatory Affairs

Position Summary

We are seeking an experienced and proactive Sr. Manager / AGM – Drug Liaison (Regulatory & Government Affairs) to manage and strengthen the organization's liaison with CDSCO, State Drug Control Authorities, and other Central and State Government bodies related to the pharmaceutical industry. The incumbent will be responsible for ensuring timely regulatory approvals, maintaining statutory compliance, facilitating government interactions, and representing the organization before regulatory authorities.

The ideal candidate should possess extensive knowledge of the Indian pharmaceutical regulatory framework, strong government networking skills, and hands-on experience in handling CDSCO approvals, Sugam Portal submissions, licensing, inspections, and regulatory compliance.

Key Responsibilities

Regulatory Liaison & Government Relations

• Act as the primary liaison between the company and CDSCO, State FDA/Drug Controllers, NPPA, State Licensing Authorities, and other government departments.
• Build and maintain professional relationships with regulatory officials to facilitate smooth regulatory processes.
• Coordinate with Central and State Government authorities for approvals, licenses, permissions, and statutory clearances.
• Represent the organization during meetings with regulatory agencies and government bodies.

Compliance

• Respond promptly to regulatory queries, deficiencies, and clarification requests.
• Ensure compliance with CDSCO regulations, Drugs & Cosmetics Act & Rules, and other statutory requirements.

Licensing & Approvals

• Coordinate activities related to:
• Manufacturing Licenses
• Product Permissions
• Import & Export Regulatory Approvals
• Test Licenses
• Additional Product Registrations
• License Renewals and Amendments

Inspection Coordination

• Coordinate inspections conducted by CDSCO, and other regulatory authorities.
• Arrange required documentation and support inspection readiness.
• Ensure timely closure of inspection observations and regulatory commitments.

Documentation & Record Management

• Maintain complete regulatory documentation and correspondence with authorities.
• Ensure accurate record keeping of approvals, licenses, submissions, and regulatory communications.
• Prepare periodic MIS reports and regulatory status updates for management.

Cross-functional Coordination

• Work closely with Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control, Legal, Supply Chain, and Business Development teams.
• Provide regulatory guidance to internal stakeholders on government requirements and compliance matters.
• Support strategic initiatives requiring government approvals and regulatory clearances.

Desired Candidate Profile

Education

• Bachelor's degree in Pharmacy (B.Pharm) / Master's degree in Pharmacy (M.Pharm)
• Additional qualification in Regulatory Affairs will be an added advantage.

Experience

• 8–12 years of relevant experience in Regulatory Affairs and Government Liaison within the pharmaceutical industry.
• Proven experience in dealing with CDSCO, State Drug Controllers, FDA, and other government authorities.
• Experience with the Sugam Portal and regulatory submission processes.
• Experience in licensing, product approvals, inspections, and regulatory compliance.

Technical Competencies

• Thorough knowledge of the Drugs & Cosmetics Act & Rules and CDSCO regulations.
• Strong understanding of pharmaceutical regulatory procedures in India.
• Expertise in Sugam Portal operations.
• Regulatory documentation and dossier management.
• Government liaison and stakeholder management.
• Knowledge of licensing procedures and statutory approvals.
• Excellent documentation and report-writing skills.

Behavioral Competencies

• Strong communication and interpersonal skills.
• Excellent relationship-building and networking abilities.
• High level of integrity and professionalism.
• Strong negotiation and influencing skills.
• Ability to work under pressure and manage multiple priorities.
• Problem-solving and decision-making capability.
• Strong follow-up and execution skills.