Immacule Lifesciences is a leading pharmaceutical company specializing in injectable formulations, with a strong focus on regulatory compliance and global market approvals. With expertise in US FDA, EU, and other regulated markets, the company is committed to delivering high-quality generic and complex injectable products.
Job Description: Regulatory Affairs – US Market Injectable
Key Responsibilities:
✔ ANDA Submissions – Compile Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages.
✔ Deficiency Responses – Address FDA queries (IRs, CRLs, DRLs) with timely and accurate responses.
✔ Labeling Compliance – Prepare SPL files and annotated label comparisons vs. RLD.
✔ Regulatory Correspondence – Draft Controlled Correspondence for bioequivalence, Q1/Q2 sameness, and ingredient evaluations.
✔ Post-Approval Changes – File supplements (PAS, CBE-30, CBE-0) for product lifecycle management.
✔ EU Market Submissions – Compile MAAs via DCP, MRP, and Centralized Procedures (Modules 1–5).
✔ Pre-ANDA Meetings – Engage with USFDA for complex injectable product approvals.
✔ DMF Review – Evaluate Drug Master Files, especially for peptides and complex formulations.
Eligibility & Qualifications
✅ Education: Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
✅ Experience: 3+ years in US FDA regulatory affairs (injectables preferred).
✅ Skills:
- Strong knowledge of eCTD submissions and US FDA guidelines.
- Expertise in sterility assurance and GMP compliance.
- Familiarity with EU regulatory pathways (DCP, MRP).
✅ Soft Skills: Analytical thinking, attention to detail, strong communication.
Benefits & Work Culture
🔹 Competitive salary with performance incentives.
🔹 On-site role in Ahmedabad with a collaborative work environment.
🔹 Career growth opportunities in regulatory affairs and global submissions.
🔹 Exposure to complex injectables and cutting-edge pharmaceutical developments.
How to Apply
📩 Email: Send your resume to pratik.joshi@acmegenerics.in
📍 Location: Ahmedabad, Gujarat (On-site)
