Senior Executive, Labeling Reviewer at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

07 Jun, 26

Salary

0.0

Posted On

09 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Labeling Review, Regulatory Affairs, ANDA Submissions, Cross-Functional Team Coordination, FDA Guidance, Labeling Regulations, Change Controls, Annual Reporting, Safety Labeling, Patent Knowledge, Exclusivity Knowledge, SOP Development, Attention To Detail, Priority Management, Verbal Communication, Written Communication

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities: * Compile and perform initial review of US labeling documents for: * Original ANDA submissions * Additional strength submissions * Coordinate with Cross-Functional Teams (CFTs) to ensure alignment on priorities, roles, and regulatory filing timelines. * Proactively follow up with internal stakeholders to obtain labeling documents within defined timelines and ensure completeness of all labeling modules prior to submission. * Stay current with US labeling regulations, FDA guidance, and industry best practices. * Ensure availability and readiness of all labeling modules for: * Complete Response (CR) * Information Request (IR) * Deficiency Response Letter (DRL) submissions Coordinate with cross-functional teams to collect and compile required documents for responses. * Ensure 100% launch readiness for all new products with zero labeling-related issues, including: * Issuance of most current, approved labeling (Ok-To-Print) * Timely availability of printed labeling for product launch * Drug listing completion for first-launch products post-approval * Assist in reviewing Reference Listed Drug (RLD) labeling updates for OSD and Injectables and ensure timely submission of updated labeling modules. Coordinate with supervisor to align priorities. * Initiate and facilitate Change Controls and Labeling Review Committee (LRC) activities for all labeling changes. * Address and track annual reportable labeling changes. * Manage Safety Labeling Change Notifications in compliance with regulatory requirements. * Demonstrate strong knowledge of Patent and Exclusivity considerations, including labeling carve-outs. * Support development, revision, and compliance of labeling SOPs. Required Skills & Competencies: * Strong understanding of US FDA labeling regulations for OSD and Injectable products * Excellent written and verbal English communication skills * Strong coordination, follow-up, and documentation skills * High attention to detail with the ability to manage multiple priorities effectively

Responsibilities

This role involves compiling and initially reviewing US labeling documents for ANDA and additional strength submissions, while coordinating with cross-functional teams to ensure alignment on timelines and priorities. The executive must also ensure 100% launch readiness for new products and manage various labeling change notifications and updates.