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Global Program Regulatory Manager (Gprm)

Novartis
Novartis
2+ years
Not Disclosed
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, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Global Program Regulatory Manager (GPRM)

Location: Hyderabad (Office)
Job Type: Full-Time
Experience Required: Minimum 2+ Years in Regulatory Affairs & Pharmaceutical Development
Application Deadline: May 15, 2026
Industry: Pharmaceutical / Regulatory Affairs / Clinical Development


Job Overview

We are seeking a highly motivated and detail-oriented Global Program Regulatory Manager (GPRM) to support the development and implementation of global regulatory strategies across product development, clinical trials, registration, and post-approval activities. The selected candidate will work closely with Regulatory Affairs Program Leads and cross-functional global teams to coordinate regulatory submissions, health authority interactions, and compliance activities across assigned regions.

This role is ideal for professionals with experience in regulatory affairs, pharmaceutical development, clinical trial submissions, and global health authority regulations.


Key Responsibilities

Global Regulatory Strategy

  • Support development and implementation of global regulatory strategies for assigned products and regions.
  • Provide strategic regulatory input for:
    • Clinical development programs
    • Registration pathways
    • Post-approval lifecycle activities
  • Contribute to:
    • Regulatory designations
    • Innovative regulatory approaches
    • Cross-functional development strategies
  • Coordinate regulatory readiness activities with:
    • Country organizations
    • Global regions
    • Internal functional teams

Health Authority Interactions

  • Coordinate and support interactions with global Health Authorities (HAs) including:
    • FDA
    • EMA
    • Regional regulatory agencies
  • Assist in preparation and facilitation of:
    • Health Authority meetings
    • Regulatory responses
    • Submission review activities
  • May serve as liaison between regulatory teams and health authorities in assigned regions.

Regulatory Submission Management

  • Lead planning, preparation, and submission of:
    • Clinical trial applications
    • Initial registrations
    • Post-approval regulatory submissions
    • Maintenance applications
  • Support authoring and review of:
    • Module 1 documents
    • Product information
    • Regulatory documentation
    • Safety reports
  • Coordinate implementation of global registration strategies into regional submissions worldwide.

Compliance & Regulatory Operations

  • Ensure timely submission of:
    • Aggregate safety reports
    • Annual reports
    • Regulatory renewals
    • Compliance documentation
  • Maintain regulatory information within:
    • Compliance databases
    • Document management systems
  • Ensure adherence to:
    • Regulatory standards
    • Internal SOPs
    • Quality and compliance requirements

Cross-Functional Collaboration

  • Participate in Regulatory Affairs sub-teams and represent RA in cross-functional discussions.
  • Collaborate with:
    • Clinical Teams
    • Safety Teams
    • Medical Affairs
    • Quality Assurance
    • Global Product Development Teams
  • Provide regulatory input into:
    • Clinical protocols
    • Investigator Brochures (IB)
    • Safety reports
    • Development deliverables

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
    • Clinical Research
    • Drug Development
    • Pharmaceutical Compliance
    • Project Management

Experience Requirements

  • Minimum 2+ years of experience in:
    • Regulatory Affairs
    • Pharmaceutical Development
    • Clinical Trial Regulatory Operations
    • Regulatory Submission Management
  • Experience working across:
    • Global regulatory regions
    • Cross-functional pharmaceutical teams
    • Clinical development programs
  • Understanding of:
    • Clinical trials
    • Scientific data interpretation
    • Drug development lifecycle
    • Health authority requirements

Freshers are not eligible for this position.