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Regulatory Submissions Manager

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ICON
6-10 years
Not Disclosed
Bangalore, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills:

Regulatory Submissions Manager

Location: Bangalore, India
Work Mode: Remote
Job Type: Full-Time
Experience Required: Minimum 6–10+ Years in Regulatory Affairs or Regulatory Submissions
Industry: Pharmaceutical / Biotechnology / Clinical Research / CRO


Job Overview

We are seeking an experienced and detail-oriented Regulatory Submissions Manager to lead global regulatory submission activities and support drug development programs across multiple regulatory regions. The selected candidate will play a key role in managing regulatory operations, coordinating agency interactions, and ensuring compliance with international regulatory standards throughout the product lifecycle.

This role is ideal for professionals with expertise in regulatory affairs, CTA/IND/MAA submissions, clinical trial applications, and global regulatory strategy within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Regulatory Submission Management

  • Lead and manage:
    • Regulatory submission activities
    • CTA submissions
    • IND applications
    • MAA submissions
    • Post-approval regulatory activities
  • Ensure timely and high-quality preparation, review, and submission of regulatory documentation.
  • Independently manage regulatory deliverables across multiple projects and product development stages.

Global Regulatory Affairs Support

  • Provide regulatory guidance and strategic support to:
    • Internal teams
    • Cross-functional departments
    • Clinical development teams
    • Project stakeholders
  • Support regulatory planning for:
    • Early-stage development
    • Clinical trial applications
    • Marketing authorization submissions
    • Product lifecycle management

Agency Interactions & Compliance

  • Participate in:
    • Health authority interactions
    • Regulatory meetings
    • Agency communications
    • Submission discussions
  • Ensure compliance with:
    • Global regulatory requirements
    • Industry guidelines
    • Regulatory standards
    • Internal SOPs
  • Support responses to regulatory authority queries and information requests.

Cross-Functional Collaboration

  • Collaborate closely with:
    • Clinical Operations
    • Regulatory teams
    • Medical Writing
    • Quality Assurance
    • Biostatistics
    • Project Management teams
  • Ensure regulatory activities align with:
    • Project timelines
    • Development strategies
    • Business objectives
    • Submission goals

Regulatory Process Improvement

  • Contribute to development and enhancement of:
    • Regulatory best practices
    • Submission workflows
    • Operational efficiencies
    • Compliance processes
  • Stay updated with:
    • Global regulatory trends
    • Regulatory guidelines
    • Industry standards
    • Emerging submission requirements

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Healthcare
    • Clinical Research
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree preferred in:
    • Regulatory Affairs
    • Pharmaceutical Sciences
    • Life Sciences
    • Healthcare Management
    • Clinical Research

Experience Requirements

Required Experience

  • Minimum 6–10+ years of experience in:
    • Regulatory Affairs
    • Regulatory Submissions
    • Clinical Research
    • Pharmaceutical or Biotechnology industry
    • CRO environments
  • Strong experience with:
    • CTA submissions
    • IND applications
    • MAA submissions
    • Health authority interactions
    • Global regulatory documentation

Leadership Experience

  • Proven ability to:
    • Lead internal teams
    • Manage regulatory projects independently
    • Coordinate cross-functional activities
    • Deliver complex regulatory submissions

Freshers are not eligible for this managerial role.