Senior Executive, Labeling Reviewer

Department Icon Risk Management & Compliance
93+ Applicants
Posted: 1 month ago
0-1 years
Ahmedabad, Gujarat
work from office

Posted: 1 month ago
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Applicants: 94+
Job Description
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Job 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:
  • Artwork Approval Process
  • Artbrand
  • TrackMate
  • Labdoxx
  • Other current and future ALI-related platforms and tools

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  • 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.
Qualifications
Masters Degree

Skills

Issue Resolution

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Important dates & deadlines?

Application Deadline

19 Jul 26, 03:30 PM IST

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Senior Executive, Labeling Reviewer

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