Regulatory Affairs Executive/Asst. Manager at Immacule Lifesciences

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.

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!