Job Title: Regulatory Affairs Manager
Department: Clinical Operations
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Application End Date: 12 May 2025
Job Responsibilities:
IQVIA is seeking a Regulatory Affairs Manager to lead and develop global regulatory Chemistry, Manufacturing, and Controls (CMC) strategies. The successful candidate will ensure the timely approval of marketing applications, clinical trial applications, and post-approval submissions by managing and preparing high-quality regulatory documentation.
Key Responsibilities:
Develop global CMC regulatory strategies to support acceptance and rapid review/approval of submissions.
Write and compile CMC sections for clinical trial applications, variations/supplements, and global registration submissions.
Lead a team of subject matter experts (SMEs) with a strong understanding of eCTD requirements for Quality modules across various submission types.
Review data for dossier preparation, identify gaps/risks, and communicate regulatory implications to stakeholders.
Manage and respond to Health Authority queries to support early product approval.
Interact and negotiate with global Health Authorities on CMC-related issues.
Develop and manage CMC submission timelines and project plans.
Assess global regulatory impact of proposed manufacturing changes and develop supporting strategies.
Provide expert guidance on ICH, FDA, and EU CMC regulatory guidelines.
Collaborate with internal teams and external partners (e.g., CMOs) to align regulatory strategies.
Represent Regulatory Affairs CMC on cross-functional teams to ensure successful execution of regulatory objectives.
Ensure CMC dossiers and related regulatory information are accurately stored in Veeva in line with internal policies.
Qualifications & Skills:
Demonstrated expertise in global CMC regulatory strategy and documentation.
Strong working knowledge of eCTD structure and global regulatory guidelines (ICH, FDA, EU).
Experience in leading regulatory responses and managing communication with Health Authorities.
Excellent project management and cross-functional collaboration skills.
Proficiency in regulatory systems and tools, preferably Veeva Vault.
Effective written and verbal communication skills with the ability to manage complex regulatory issues.
About IQVIA:
IQVIA is a global leader in clinical research, healthcare intelligence, and data analytics, driving innovation to improve patient outcomes and enable the advancement of modern medical solutions. Learn more at IQVIA Careers
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