Regulatory Affairs Executive/Asst. Manager at Immacule Lifesciences

Immacule Lifesciences Pvt. Ltd Recruitment

    Immacule Lifesciences, located in vibrant Ahmedabad, invites experienced professionals to join our dynamic team as a Regulatory Affairs Executive/Asst. Manager. If you’re passionate about revolutionizing healthcare through regulatory excellence, this role is tailor-made for you!

    Role Overview: As part of our Regulatory Affairs team focusing on Injectable products for the US and European markets, you will play a pivotal role in ensuring regulatory compliance and product excellence.

    Job Title : Regulatory affairs Executive, Regulatory affairs Asstant Manager
    Department: Regulatory Affairs – Injectable (US/Europe)
    Experience: 4 to10 Years
    Qualification: B Pharmacy, M Pharmacy
    Location: Immacule Lifesciences, Ahmedabad

    Key Responsibilities:

    • Spearhead the compilation of ANDAs and 505(b)(2) applications with USFDA, including pre-ANDA meetings for complex products.
    • Conduct thorough reviews of DMFs for complex peptide drug substances, ensuring accuracy and compliance.
    • Ensure timely response submissions for ANDA deficiencies, IR, CRL, and DRL, maintaining a high standard of regulatory readiness.
    • Drive Labeling compilation, including SPL and side-by-side comparisons against RLD labels, highlighting essential changes.
    • Lead QBR compilations for drug substance and product, including Sterility assurance QBR, ensuring quality standards are met.
    • Demonstrate expertise in handling drug-device combination regulations, including Human Factor Engineering studies protocols and reports.
    • Oversee controlled correspondence submissions with regulatory authorities for bioequivalence recommendations and inactive ingredient levels.
    • Manage Supplements filling for facility changes and CMC-related modifications, supporting product life cycle management.
    • Ensure product compliance with regulatory approvals and requirements, maintaining accurate trackers for filing status, deficiencies, and new launches.
    Immacule Lifesciences Pvt. Ltd Recruitment
    Immacule Lifesciences Pvt. Ltd Recruitment

    How to Apply: Are you ready to make a significant impact in the pharmaceutical regulatory landscape? Share your updated resume with us at career@acmeformulation.com or WhatsApp us at 9418155173. Join us on our journey to innovate and enhance healthcare worldwide!

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