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International Program Regulatory Director (Iprd)

Novartis
Novartis
10+ years
preferred by company
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines Skills: Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution

International Program Regulatory Director (IPRD)

Location: Hyderabad (Office)
Job Type: Full-Time
Experience Required: Minimum 10+ Years in Regulatory Affairs & Product Development
Application Deadline: May 15, 2026
Industry: Pharmaceutical / Regulatory Affairs / Drug Development


Job Overview

We are seeking a highly experienced and strategic International Program Regulatory Director (IPRD) to lead global and regional regulatory planning, registration strategy execution, and international regulatory operations across assigned pharmaceutical portfolios. The selected candidate will provide strategic regulatory leadership for international markets while collaborating with global cross-functional teams to ensure efficient registration planning, regulatory compliance, and successful product approvals.

This role is ideal for professionals with extensive expertise in regulatory affairs, global product development, health authority interactions, registration strategy, and international market expansion within the pharmaceutical industry.


Key Responsibilities

Global & International Regulatory Strategy

  • Develop and oversee optimal international registration strategies and execution plans for assigned product portfolios.
  • Lead alignment and sign-off processes with:
    • Global regulatory teams
    • Commercial stakeholders
    • Drug development units (DU)
    • Regional and country regulatory teams
  • Ensure timely dissemination of approved regulatory plans across international stakeholders and markets excluding China, Japan, and the European Union.

International Regulatory Team Leadership

  • Lead and manage the International Regulatory Affairs (INT RA) subteam across assigned countries.
  • Collaborate with:
    • Global Regulatory Affairs subteams
    • Country regulatory associates
    • Regional cross-functional teams
  • Mentor International Program Regulatory Managers and Senior Managers on:
    • Pipeline management
    • Compliance standards
    • Regulatory processes
    • Strategic execution
  • Support recruitment, development, and performance growth of regulatory team members.

Regulatory Submission & Registration Management

  • Oversee maintenance and execution of registration plans for international markets.
  • Coordinate:
    • Submission dossier preparation
    • Ancillary document procurement
    • Health Authority (HA) responses
    • Milestone tracking activities
  • Support geographic expansion plans and registration activities for emerging markets and strategic brands.
  • Partner with global policy and regulatory teams to interpret and implement evolving international regulatory requirements.

Health Authority & Stakeholder Management

  • Represent regulatory teams in:
    • Global cross-functional initiatives
    • Regulatory committees
    • Strategic planning discussions
  • Maintain strong engagement with:
    • Health Authorities
    • Country organizations
    • Global development teams
    • Commercial stakeholders
  • Lead strategic negotiations and communication activities with regulatory authorities where required.

Compliance, Risk Management & Operational Excellence

  • Ensure maintenance of:
    • Country regulatory requirement repositories
    • Registration plan documentation
    • Regulatory communication systems
  • Identify and mitigate:
    • Regulatory risks
    • Operational hurdles
    • Compliance challenges
  • Lead initiatives to improve:
    • Regulatory operational efficiency
    • Functional excellence
    • Cross-functional collaboration
  • Support quality compliance and strategic risk assessments across international regulatory operations.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree (BS) or Master’s Degree (MS) in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Biomedical Sciences
    • Chemistry
    • Regulatory Affairs
    • Or related scientific disciplines

Preferred Qualifications

  • Advanced Degree preferred:
    • PharmD
    • MD
    • PhD
    • Master’s in Regulatory Affairs
  • Certifications in:
    • Regulatory Affairs
    • Drug Development
    • Project Management
    • Pharmaceutical Compliance
    • Clinical Research