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Global Regulatory Submission Manager

Novartis
Novartis
5+ years
Not Disclosed
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree (BS) in: Life Sciences Pharmacy Biotechnology Chemistry Biomedical Sciences Regulatory Affairs Or related scientific disciplines Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model

Global Regulatory Submission Manager

Location: Hyderabad, Telangana (Office)
Job Type: Full-Time
Experience Required: 5+ Years in Regulatory Affairs or Regulatory Submissions
Application Deadline: May 15, 2026
Industry: Pharmaceutical / Regulatory Affairs / Life Sciences


Job Overview

We are seeking an experienced and detail-oriented Global Regulatory Submission Manager to manage complex global regulatory submission projects and support regulatory operations for pharmaceutical product development and lifecycle management. The selected candidate will be responsible for ensuring regulatory compliance, maintaining controlled documentation systems, coordinating submission activities, and supporting global regulatory strategies across multiple products and markets.

This role is ideal for professionals with strong expertise in regulatory affairs, submission publishing, global health authority guidelines, document management systems, and pharmaceutical development processes.


Key Responsibilities

Global Regulatory Submission Management

  • Manage multiple large-scale and complex global regulatory submission projects simultaneously.
  • Coordinate preparation, compilation, and submission of:
    • Regulatory dossiers
    • Submission components
    • Technical documentation
    • Product registration files
  • Support regulatory submission publishing activities and ensure adherence to global submission standards.

Regulatory Strategy & Compliance

  • Contribute to technical and strategic regulatory planning for:
    • Product development
    • Product registration
    • Lifecycle maintenance activities
  • Ensure compliance with:
    • FDA regulations
    • ICH guidelines
    • EMA directives
    • Global health authority requirements
  • Interpret and enforce:
    • Documentation standards
    • SOPs
    • Regulatory formatting policies
    • Record retention requirements

Documentation & Records Management

  • Maintain controlled documentation systems and electronic records retention processes.
  • Ensure proper classification, maintenance, and archival of:
    • Technical documents
    • Regulatory records
    • Submission materials
  • Support technical and non-technical documentation change management activities.

Project Coordination & Cross-Functional Collaboration

  • Collaborate with:
    • Regulatory Affairs Teams
    • Clinical Teams
    • Quality Assurance
    • Manufacturing
    • Global Product Development Teams
  • Coordinate with internal and external stakeholders to ensure timely submission deliverables.
  • Contribute to implementation of global systems, tools, and operational processes supporting regulatory functions.

Data Analysis & Reporting

  • Analyze and evaluate regulatory data and documentation.
  • Prepare:
    • Executive summaries
    • Information abstracts
    • Submission reports
    • Regulatory communication materials
  • Support resolution of regulatory issues using analytical and problem-solving skills.

Required Qualifications

Educational Qualifications

Required Qualification:

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

Preferred Qualifications

  • Master’s Degree preferred in:
    • Regulatory Affairs
    • Pharmaceutical Sciences
    • Life Sciences
    • Biotechnology
    • Healthcare Management
  • Certifications in:
    • Regulatory Affairs
    • Drug Development
    • Clinical Research
    • Pharmaceutical Compliance
    • Project Management