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.
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Immacule Lifesciences Pvt. Ltd Recruitment[/caption]
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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