Assistant Manager - Regulatory Affairs (US Market)

Summary:

Responsible for Compilation, review and submission of ANDA and responding to queries. Compilation of Controlled correspondences, Scientific package to USFDA.

Managing post approval changes and annual updates. Review of regulatory updates and evaluation of its impact on ongoing / planned submission activities.

KRA:

1. US Regulatory Submissions

• Prepare, compile, review, and submit regulatory dossiers in eCTD format.
• Review CMC documents, specifications, analytical methods, validation reports, stability data, and manufacturing records, DMF, PDR etc.
• Prepare responses to Information Requests (IRs), Complete Response Letters (CRLs), and FDA deficiencies.
• Coordinate with R&D, Quality, Manufacturing, and analytical teams for timely closure of regulatory queries.
• Manage post-approval changes for approved ANDAs

2. Lifecycle Management

• Assess CMC, labeling, packaging, manufacturing, and supplier changes for regulatory impact.
• Prepare and review submission documents supporting product lifecycle management.

3. Regulatory Intelligence

• Monitor USFDA guidance documents, Federal Register notices, Orange Book updates, and industry trends.
• Assess impact of regulatory changes on existing and pipeline products.
• Provide regulatory recommendations to cross-functional teams during product development.

4. Communication with Regulatory Agencies

• Support interactions with USFDA regarding submissions and regulatory strategy.
• Coordinate submission-related correspondence through ESG and FDA portals.
• Maintain records of agency communications.

5. Cross-Functional Coordination

• Collaborate with: Formulation Development, Analytical Development,

Quality Assurance, Manufacturing Supply Chain, Business Development

6. Labeling & Packaging Review

• Review labelling as per FDA labeling requirements.
• Support implementation of labeling updates.

7. Inspection & Audit Support

• Assist in preparing regulatory documentation for USFDA inspections.
• Support audit readiness activities.
• Participate in CAPA implementation and effectiveness verification.

Must Haves:

• Handled US Filings for ANDA and good knowledge of USFDA regulation
• Have experience of handling of sterile dosage forms like ophthalmic, injectables.
• Good communication skills (written and spoken)
• Handled eCTD publishing tools

Qualification & Experience

• M.Pharm from a reputed institute with strong academic credentials.
• 6-8 Years of relevant experience.