We're Hiring | Executive / Sr. Executive – Regulatory Affairs
Complex Products (Sterile, Nasal, Transdermal & Topical Dosage Forms)

Location: Ahmedabad
Qualification: B.Pharm / M.Pharm
Experience: 5-9 Years

About the Role
Amneal Pharmaceuticals is seeking a highly motivated Regulatory Affairs professional with hands-on experience in Complex Products, including Sterile (Aseptic & Terminal Sterilized), Nasal, Transdermal, and Topical Dosage Forms. This role offers an exciting prospect to work on product development, regulatory submissions, agency interactions, deficiency management, and lifecycle maintenance activities for the US market.

Key Responsibilities
Regulatory Submissions & Strategy
• Prepare, review, compile, and submit INDs, NDAs, ANDAs, and associated amendments to the US FDA.
• Develop and execute regulatory strategies for product development, submissions, lifecycle management, and deficiency responses.
• Ensure high-quality, compliance-driven submissions aligned with FDA regulations, ICH guidelines, and business requirements.




• Drive timely submissions while minimizing deficiencies and supporting successful approvals.

Complex Product Regulatory Support
• Manage regulatory activities for complex products, including Sterile, Nasal, Transdermal, and Topical dosage forms.
• Assess formulation and product-specific regulatory requirements to support effective filing strategies.
• Provide regulatory guidance throughout the product development lifecycle.

Health Authority Interactions
• Prepare and finalize Controlled Correspondences with regulatory agencies.
• Author and review Pre-ANDA, Pre-IND, Pre-NDA, and scientific advice meeting packages.
• Support regulatory interactions and strategic discussions with health authorities.

Deficiency Management
• Evaluate agency deficiency letters and perform detailed gap assessments.
• Coordinate with cross-functional teams to develop scientifically sound and timely responses.
• Drive closure of regulatory queries

📌 Executive / Sr. Executive – Regulatory Affairs (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad