Regulatory Affairs Manager

We're hiring a hands-on Manager - Regulatory Affairs to own USFDA submissions, ANDA lifecycle management, and facility/product compliance for external application products manufactured at our facility. You'll report to the Regulatory Head/Director and work closely with Quality, Manufacturing, and R&D teams to navigate FDA requirements and bring products to market efficiently.

This is an execution-driven role with direct ownership of USFDA outcomes -not a consulting or coordination role.

What You'll Be Responsible For

USFDA Submissions & CMC Execution

• Prepare, compile, review, validate, and submit ANDA dossiers for external application products (creams, ointments, gels, lotions, and similar dosage forms)
• Manage CMC sections for topical/external dosage forms , including formulation rationale, excipient justification, specifications, and st...