Manager Pharma Compliance

Job Purpose

To provide compliance oversight and ensure effective management of regulatory adherence across retail and wholesale pharmacy operations for the assigned region. The role acts as the regional custodian of compliance, assisting in the procurement and management of requisite licenses, ensuring compliance with statutory requirements, and tracking any deviations via periodic store audits.

Qualification

D.Pharm / B.Pharm/M Pharm

PQE

3 - 5 Yrs

Description of Responsibility

Compliance

• Assist in the procurement, management, and timely renewal of requisite drug licenses and statutory registrations.
• Conduct periodic store audits on various parameters, ensuring compliance under the Drugs and Cosmetics Act, Pharmacy Act, Teleconsultation guidelines, Drugs and Magic Remedies Act, Drug Price Control Order (DPCO), NDPS Act, Legal Metrology Act, etc.
• Maintain registers and records, tracking validity of the licenses and post-registration compliances & license conditions.
• Ensure compliance with legal requirements under various enactments and internal policies.

Inspections, Notices & Documentation

• Be the first responder for FDA / drug inspector inspections. Be present on site or coordinate it and ensure records are inspection-ready.
• Prepare responses to show cause notices, deficiency letters and other regulatory correspondence, in coordination with Legal and the Senior Director.
• Identify gaps from audits and inspections, document findings, and drive CAPA to closure within timelines.
• Maintain a centralised, up-to-date repository of all regional licences, notices and correspondence.
• Report periodically to the Senior Director on compliance health, open notices and risks.

Government & Stakeholder Relationship Management

• Liaise closely with CDSCO, State Drug Control Departments (FDA), health ministries, and other local regulatory bodies. Visit offices when required to follow up on licences, inspections and notices.
• Build and maintain professional, ethical working relationships with government and law enforcement officers.

Desired Skills

• Deep, functional knowledge of Indian pharmaceutical laws, drug pricing orders and telemedicine regulations.
• Working knowledge of state-specific licensing processes and FDA practices in the region.
• Proven experience handling inspections and show cause notices, and managing licensing vendors or consultants.
• Strong audit acumen, attention to detail and a strategic approach to compliance and risk.
• Willingness to travel across the region for audits, inspections and government visits.
• Strong written and verbal communication in English and the local language is preferred.

Competency

• Reliability, dependability: Works hard and does what it takes to get results and meets deadlines. Takes accountability and works well in a cross-functional team.
• Communication: Writes, speaks, and presents information effectively, clearly, and with brevity. Confidently communicates with government officials and internal staff.
• Composure: Handles unexpected events calmly and acts with the highest level of professionalism and maturity during crisis situations.
• Dealing with ambiguity: Works effectively in situations involving uncertainty; effectively handles multiple projects or tasks at the same time.
• Company-wide perspective: Able to assess the broader and deeper impact of compliance decisions, focusing on what is right for the overall business.

External Stakeholder Management

• Appoint, manage and review external vendors such as licensing consultants, audit and pharmacy-compliance agencies, and local counsel.
• Validate and process vendor’s work, and escalate delays or lapses.