Regulatory Affairs – US Market Injectable

We are seeking a seasoned Regulatory Affairs professional with extensive experience in injectable dossiers and a solid understanding of US FDA regulatory pathways. The ideal candidate will play a critical role in ensuring successful submissions and lifecycle management of injectable products for regulated markets, especially the United States.

Key Responsibilities:

Compile Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings.

Submit timely responses to ANDA deficiencies (IRs, CRLs, DRLs).

Handle labeling compilation, including SPL files and annotated comparisons vs. RLD labels.

Prepare Controlled Correspondence with regulatory bodies for:

Bioequivalence recommendations

Inactive ingredient levels

Q1/Q2 sameness evaluation during early development

File supplements for post-approval changes (e.g., PAS, CBE-30, CBE-0).

Oversee product lifecycle management, including change control approvals and continuity through effective supplement filings.

Compile Marketing Authorization Applications (MAAs) for EU via DCP, MRP, and Centralized Procedure (Modules 1–5).

Manage pre-ANDA meeting submissions for complex products with USFDA.

Review Drug Master Files (DMFs), particularly for complex peptides.

If this sounds like you—or someone in your network—please share your profile or connect with us at: 📧 pratik.joshi@acmegenerics.in