Executive – Labeling Reviewer (US Regulatory | OSD & Injectable)
Location: Ahmedabad, Gujarat, India
Department: Labeling & Regulatory Affairs
Job Type: Full-Time
Application Deadline: 16 March 2026
Job ID: 7249
Qualification Required: B.Pharm / M.Pharm
Role Overview
We are hiring an Executive – Labeling Reviewer to support U.S. regulatory submissions for Oral Solid Dosage (OSD) and Injectable products. This role is responsible for compilation, review, and lifecycle management of labeling documentation for original ANDA submissions, additional strength filings, deficiency responses, and post-approval updates.
The position requires strong knowledge of US FDA labeling requirements, threshold analysis, safety labeling changes, patent and exclusivity carve-outs, and drug listing compliance. The ideal candidate will ensure 100% launch readiness with zero labeling deficiencies while coordinating cross-functionally to meet submission timelines.
This opportunity is ideal for pharmacy professionals with hands-on experience in US generic labeling and regulatory documentation.
Key Responsibilities
ANDA & Submission Support
Compile and perform initial review of labeling documents for OSD and Injectable products for original ANDA and additional strength submissions.
Ensure availability of all labeling modules for CR, IR, and DRL submissions within defined timelines.
Coordinate with cross-functional teams (CFT) to align priorities and filing schedules.
Follow up with departments to collect required documents for timely regulatory submissions.
Deficiency & Query Management
Perform initial review of deficiency letters and queries related to US labeling.
Compile and submit deficiency responses in coordination with relevant teams.
Support timely submission of labeling updates in response to regulatory queries.
Labeling Compliance & Regulatory Oversight
Stay updated with current US FDA labeling practices and regulatory guidelines.
Conduct threshold analysis for labeling sections.
Review and implement Safety Labeling Change Notifications.
Ensure compliance with patent and exclusivity carve-out requirements.
Assist in reviewing Reference Listed Drug (RLD) updates for OSD and Injectable products.
Launch & Lifecycle Management
Ensure 100% launch readiness with zero labeling issues.
Issue updated and approved labeling documents marked Ok-To-Print.
Approve vendor soft copies, transparencies, shade cards, and first print copies.
Create Barcode Grade Reports and manage drug listing activities for first-launch products.
Support labeling documentation for site transfer and additional site transfer projects.
Facilitate labeling introduction for third-party manufacturing partners.
Change Control & Documentation
Initiate and manage Change Controls and Labeling Review Committee (LRC) processes.
Compile labeling templates for Annual Reports, PADER, and APQR submissions.
Address annual reportable labeling changes in compliance with US regulatory timelines.
Work in alignment with internal labeling SOPs and quality systems.
Required Experience
2 to 5 years of experience in US regulatory labeling for OSD and Injectable products.
Hands-on experience in ANDA labeling compilation and review.
Experience handling US FDA deficiency responses related to labeling.
Practical knowledge of threshold analysis, safety labeling updates, and exclusivity carve-outs.
Experience supporting product launch readiness and drug listing submissions.
Exposure to Change Control processes and cross-functional regulatory coordination.
Educational Qualification
Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).
Key Skills & Competencies
Strong understanding of US FDA labeling regulations and submission pathways.
Knowledge of patent and exclusivity considerations in labeling strategy.
Ability to manage multiple submissions under strict regulatory timelines.
Strong documentation, analytical, and coordination skills.
Excellent written and verbal communication skills in English.
Detail-oriented with a compliance-driven mindset.
Why This Role Matters
Labeling accuracy is critical to regulatory approval, patient safety, and successful product launch in the United States market. This role ensures compliant, high-quality labeling documentation across the product lifecycle, directly supporting regulatory success and commercial readiness.
Apply now through ThePharmaDaily.com to build your career in US regulatory labeling, ANDA submissions, and pharmaceutical compliance.
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