Executive / Sr. Executive Regulatory Affairs

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 opportunity 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 while ensuring compliance and business continuity.

Lifecycle Management

• Assess post-approval change controls and determine appropriate filing strategies.
• Prepare and submit post-approval filings, including CBE-0, CBE-30, PAS, and other lifecycle maintenance submissions.
• Support ongoing compliance and maintenance of approved product portfolios.

Cross-Functional Collaboration

• Partner closely with R&D, Analytical Development, Quality Assurance, Manufacturing, Supply Chain, and other stakeholder groups.
• Ensure timely availability of documentation required for regulatory submissions.
• Proactively identify and escalate critical project risks and regulatory challenges.

DMF Review & Regulatory Assessment

• Review API Drug Master Files (DMFs) and provide regulatory feedback to internal stakeholders.
• Coordinate with suppliers and DMF holders to address gaps and ensure compliance with regulatory expectations.

Documentation & Compliance

• Maintain regulatory records and submission archives in an organized and inspection-ready manner.
• Stay updated on evolving FDA requirements, ICH guidelines, and industry regulations.
• Ensure all submission-related activities comply with internal procedures and regulatory requirements.

Required Skills

Regulatory Affairs for Complex Products

ANDA, NDA & IND Submission Experience

Sterile, Nasal, Transdermal & Topical Dosage Forms

Regulatory Strategy & Deficiency Response Management

FDA Correspondence & Meeting Packages

Post-Approval Filing Management (PAS, CBE-30, CBE-0)

Technical Writing & Documentation

Regulatory Compliance & Regulatory Intelligence

Cross-Functional Collaboration

Analytical Thinking & Problem Solving

Strong Communication & Stakeholder Management Skills

Preferred Candidate Profile

• 5-9 years of Regulatory Affairs experience supporting Complex Products.
• Strong understanding of FDA regulations, ICH guidelines, and regulatory submission requirements.
• Experience managing regulatory activities from development through approval and lifecycle management.
• Ability to manage multiple projects while maintaining quality, compliance, and timelines.
• Strong organizational skills with the ability to work independently in a fast-paced environment.

If you're looking to be part of a dynamic Regulatory Affairs team and contribute to innovative complex product programs, we'd love to hear from you. Please share your CV to [Confidential Information] with a cc to [HIDDEN TEXT]

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