Agent
Jobs
Applied
Tracker
Profile
    1. Jobs for you
    2. Job

    Job · 16883304

    Amneal Pharmaceuticals logo

    Assistant Manager, Regulatory Affairs

    Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago

    Undisclosed8–10 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Description:
    Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development and lifecycle management. The role oversees preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities. It contributes to monitoring regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and organizational operations. The position coordinates regulatory communications, responses, and compliance documentation for interactions with health authorities. It also collaborates with cross-functional teams to strengthen regulatory goverce, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets.

    Essential Functions:
    • Lead and review dossier compilation publishing for complex submissions
    • Oversee DMF compilation review process and submission strategies
    • Direct eCTD electronic submissions across regions
    • Manage post-submission management and health authority responses
    • Ensure robust document version control goverce
    • Monitor regulatory intelligence and assess strategic impact
    • Drive regulatory supplement reporting and lifecycle updates
    • Coordinate regulatory health authority management engagements
    • Ensure inspection readiness for DMF and audit preparedness
    • Apply risk identification mitigation in regulatory planning
    • Ensure sustained regulatory compliance across product lifecycle
    • Lead quality audit readiness initiatives


    Additional Responsibilities: Education:
    • B. Pharm B. Pharm - Required
    • M. Pharm M. Pharm - Preferred
    Experience:
    • 8 years or more in 8 - 10 Years
    Specialized Knowledge: Licenses:


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    DossierStrategy ExecutionCompilationRegulatory AffairsEctdRisk IdentificationProduct RegistrationDossier CompilationCompliance MonitoringRegulatory ComplianceoperationscomplianceProduct DevelopmentQuality Audit

    About Amneal Pharmaceuticals

    Amneal Pharmaceuticals logo

    Amneal Pharmaceuticals

    Pharma

    5.5k+

    employees

    2002

    24 years old

    Bridgewater, New Jersey

    United States (USA)

    About

    Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

    Industries

    PharmaBiotechnologyClinical Research

    Employee ratings

    1,455 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    4.2

    Employees rate it well for

    Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

    Find them on

    WebsiteLinkedInAmbitionBox reviews

    Assistant Manager, Regulatory Affairs · waiting for your command