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, SOP Preparation, Risk Assessment, Quality Management System, Compliance Management System, Training Coordination, Regulatory Labeling, Project Management, Change Management, Vendor Management, Artwork Management, Digitalization Initiatives, Cross-functional Alignment, Governance Frameworks, Risk Mitigation, Stakeholder Communication

Industry

Pharmaceutical Manufacturing

Description

* Experience with U.S. labeling systems, artwork management platforms, or regulatory labeling environments within a regulated industry is highly desirable. * Prepare, review, and revise Standard Operating Procedures (SOPs), conduct risk assessments, and ensure effective and compliant implementation. * Demonstrate strong experience working within Quality and Compliance Management System environments. * Act as the Department Training Coordinator, ensuring timely planning, execution, and documentation of training activities. * Ensure labeling compliance within the labeling department as well as across interfacing internal and external functions. * Ensure timely completion of all activities within the Global Regulatory Labeling department, meeting business, regulatory, and quality expectations. * Serve as the single point of accountability for end-to-end management, governance, and successful delivery of all ALI (Amneal Labeling Intelligence) initiatives. This is a global role with responsibility for planning, execution, and oversight of ALI initiatives across all regions. * Ensure timely execution of initiatives while maintaining regulatory and quality compliance, effective risk mitigation, and consistent adoption across all ALI digital systems, including future labeling digitalization efforts. * End-to-End Initiative Ownership Own and manage the full lifecycle delivery of ALI initiatives, including but not limited to: a. Artwork Approval Process b. Artbrand c. TrackMate d. Labdoxx e. Other current and future ALI-related platforms and tools * Drive comprehensive project planning, execution, monitoring, and closure across development, validation, and implementation phases. * Ensure strict adherence to approved timelines, defined scope, quality standards, and regulatory compliance requirements. * Facilitate strong cross-functional alignment and decision-making across Regulatory Affairs, Quality, IT, Business stakeholders, and external partners through established governance frameworks. * Manage vendor relationships, including oversight of deliverables, performance tracking, issue resolution, and escalation management. * Drive system adoption and operational readiness through structured change management, user training coordination, stakeholder communication, and post-implementation support.

Responsibilities

This role involves ensuring labeling compliance across functions, managing the end-to-end delivery of all ALI (Amneal Labeling Intelligence) initiatives globally, and driving project planning, execution, and monitoring for labeling digitalization efforts. The incumbent will also serve as the Department Training Coordinator and manage vendor relationships.