Senior Executive, Labeling Reviewer at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

US FDA labeling regulations, Regulatory filing, ANDA submissions, Cross-functional coordination, Change controls, Labeling review committee, Safety labeling change notifications, Patent and exclusivity, Labeling carve-outs, SOP development, Documentation, Attention to detail, Communication skills, Drug listing, Launch readiness

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

The role involves compiling and reviewing US labeling documents for ANDA submissions while coordinating with cross-functional teams to ensure regulatory compliance. It also requires managing labeling changes, safety notifications, and ensuring 100% launch readiness for new products.