Compliance Manager / Executive - DPCO (NPPA)

Job Title: DPCO (NPPA) Compliance Manager / Executive

Location: Gurgaon

Department: Regulatory Affairs / Pricing & Market Access

Job Summary:

We are seeking an experienced DPCO (NPPA) Compliance professional from the pharmaceutical industry with hands-on exposure to drug pricing regulations, NPPA submissions, and statutory compliance under DPCO. The role will be responsible for end-to-end compliance related to new product price approvals, price fixation, Form-V filings, and ongoing coordination with NPPA.

Key Responsibilities:

DPCO & NPPA Compliance

• Ensure complete compliance with Drug Price Control Order (DPCO), 2013 and subsequent amendments.
  
• Handle NPPA price approvals for new products, new formulations, and revised packs.
  
• Prepare, review, and submit Form-V for price fixation and price revision within prescribed timelines.
  
• Manage price notifications, price ceilings, and retail price calculations as per DPCO norms.
  

New Product & Price Approval

• Coordinate with internal teams (Marketing, Finance, SCM, QA, and Regulatory) for new product launches from a pricing and compliance perspective.
  
• Assess DPCO applicability for new products and existing portfolio.
  
• Validate MRP calculations, trade margins, and tax components in line with NPPA guidelines.
  
• Support new product approvals from NPPA prior to commercial launch.
  

Regulatory Filings & Documentation

• Maintain accurate and up-to-date records of:
  
• NPPA submissions
  
• Price approvals and acknowledgements
  
• DPCO-covered and non-DPCO product lists
  
• Respond to NPPA queries, notices, and show-cause communications, if any.
  
• Support audits, inspections, and regulatory reviews related to pricing compliance.
  

Cross-Functional Coordination

• Act as the single point of contact for NPPA-related matters.
  
• Provide advisory support to sales and marketing teams on pricing restrictions and compliance risks.
  
• Work closely with Finance for price revisions, refunds, or overcharging matters, if applicable.
  

Compliance Monitoring

• Track changes, notifications, and circulars issued by NPPA / DoP / Ministry of Chemicals & Fertilizers.
  
• Ensure timely implementation of regulatory changes across the product portfolio.
  
• Support internal compliance reviews and risk assessments related to drug pricing.
  

Key Requirements:

Education:

• Bachelors degree in Pharmacy (B.Pharm / M.Pharm) or Life Sciences
  
• Additional qualification in Regulatory Affairs or Pharma Management will be an advantage
  

Experience:

• 38 years of relevant experience in the pharmaceutical industry
  
• Mandatory hands-on experience in DPCO (NPPA) Compliance
  
• Proven exposure to:
  
• New product price approvals
  
• Form-V filing
  
• NPPA submissions and correspondence
  

Skills & Competencies:

• Strong working knowledge of DPCO 2013 and NPPA pricing framework
  
• Experience in price calculation, MRP structuring, and ceiling price application
  
• High attention to detail and compliance accuracy
  
• Ability to work independently and manage statutory timelines
  
• Strong coordination and communication skills
  

Preferred Background:

• Experience in Indian pharma companies handling domestic formulations
  
• Prior interaction with NPPA / DoP will be an added advantage