Immacule Lifescience Hiring for Regulatory Affairs

Immacule Lifescience, a USFDA approved facility specializing in injectables, is currently seeking qualified professionals to join our team. We have openings in the following departments:

Details About Immacule Lifescience Limited Hiring

• Website: https://immacule.in/
• Department: Regulatory Affairs – Injectable (US/Europe)
• Job Title: Sr. Executive/Asst. Manager
• Qualification: B.Pharma/M.Pharma
• Experience: 05-10 Years
• Batch: NA
• Salary: NA
• Job Location: Ahmedabad
• No Of Vacancies: NA
• Opening Date: 05th January 2024

About Company

Immacule is a leading pharmaceutical manufacturer specializing in liquid and lyophilized injections. Holding prestigious approvals from regulatory bodies such as UK-MHRA, ANVISA, PICS, INVIMA, and US FDA, we are dedicated to maintaining the highest standards in pharmaceutical production.

Role and Responsibilities

• Compilation of ANDAs and 505(b)(2) applications (pIND meetings, IND submissions, Brand Name submissions) with USFDA.
• Experience in the submission of pre-ANDA meetings for complex products with USFDA.
• Review of DMFs of complex peptide drug substances.
• Ensure timely response submission for ANDA deficiencies i.e., IR, CRL, and DRL.
• Ensure Labeling compilation, including SPL and side-by-side comparison against RLD labels with highlighted annotation of changes.
• QBR compilation for drug substance and drug product; Sterility assurance QBR.
• Experience with handling drug device combination regulations and understanding the requirements for the submission of Threshold Analysis report and Human Factor Engineering studies protocols and reports. Review and approve the Design History File.
• Controlled correspondence submission with regulatory authorities for bioequivalence recommendations & inactive ingredient levels and Q1 and Q2 sameness evaluation essential during the product development stage before the submission of an application.
• Supplements filing for the addition of an alternate facility and CMC-related changes, e.g., PAS, CBE-30, and CBE-0.
• Life cycle management of products & approving the change controls and ensuring product continuity through filing and timely approvals of supplements. Support continuity activities through coordination with various stakeholders.
• Approval package compilation and provide support for the launching of the approved ANDA product.
• Ensure product compliance with respect to approvals and regulatory requirements.
• Tracker management – Maintenance of ANDA filing status, deficiency, approval, labeling, and new launch status.

How to Apply

Interested candidates can share their updated resume at career@acmeformulation.com or WhatsApp on 9418155173.