Senior Manager

Job Description

Job Purpose

The Senior Manager, Global Regulatory Affairs US Post-Approval will be responsible for providing regulatory leadership and end-to-end lifecycle management for Biocons US approved product portfolio. The role will lead regulatory assessment and execution of post-approval changes for ANDAs, including manufacturing, process, formulation, analytical, specification, packaging, facility, supplier, and other CMC changes. The incumbent will determine appropriate US regulatory filing strategies, ensure timely and compliant submissions to the US FDA, manage Health Authority queries and commitments, and partner closely with Quality, Manufacturing, R&D, Analytical, Supply Chain, Project Management, Commercial, and external stakeholders to ensure compliant and timely implementation of changes.

1. US Post-Approval Regulatory Strategy

• Lead regulatory strategy for post-approval changes to US ANDAs throughout the product lifecycle for solid dosage forms and injectable preparations.

• Independently assess proposed CMC, manufacturing, analytical, packaging, facility, equipment, supplier, and process changes and determine the appropriate regulatory reporting category.

• Determine whether changes should be reported through Prior Approval Supplement (PAS), Changes Being Effected in 30 Days (CBE-30), CBE-0, or Annual Report, as applicable.

• Provide regulatory assessment in accordance with applicable 21 CFR 314.70, FDA post-approval CMC guidance, SUPAC principles, and product-specific requirements.

• Define filing and implementation strategies considering regulatory risk, business need, supply continuity, compliance requirements, and anticipated FDA review timelines.

• Provide proactive regulatory guidance to cross-functional teams during change control initiation to minimize late-stage regulatory issues.

2. Change Control & Regulatory Impact Assessment

• Review and approve change controls from a US regulatory perspective.

• Assess the potential impact of proposed changes on approved ANDAs, specifications, manufacturing processes, analytical methods, stability commitments, labeling, facilities, and other approved conditions.

• Define the appropriate supporting data package, regulatory reporting category, submission timelines, and implementation requirements.

• Ensure that changes are not commercially implemented prior to obtaining the necessary regulatory clearance or satisfying applicable reporting requirements.

• Provide regulatory input for complex or multiple simultaneous changes and establish appropriate bundling or filing strategies where scientifically and regulatorily justified.

3. ANDA Post-Approval Submission Management

• Lead planning, preparation, review, and submission of post-approval supplements and Annual Report changes for assigned products.

• Review regulatory dossiers in CTD/eCTD format for completeness, consistency, scientific adequacy, and compliance with current FDA requirements.

• Ensure appropriate documentation is available to support post-approval changes
• • Ensure submission documents are consistent with previously approved ANDA information and regulatory commitments.

4. Cross-Functional Regulatory Leadership

• Act as the primary Regulatory Affairs point of contact for assigned US post approval products.

• Coordinate with Manufacturing, Quality Assurance, Quality Control, R&D, Analytical Development, Packaging, Supply Chain, Project Management, Commercial, Legal, Finance, and other relevant functions to obtain required submission documentation.

• Provide clear regulatory requirements, deliverables, ownership, and timelines to cross-functional stakeholders.

• Identify regulatory gaps and potential submission risks early and drive teams toward timely resolution.

• Lead cross-functional discussions for complex regulatory changes where alignment between technical functions is required.

5. Document Adequacy & Compliance Review

• Ensure adequacy, completeness, consistency, and compliance of documentation received from cross-functional functions before inclusion in regulatory submissions.

• Perform critical review of technical documents and challenge inconsistencies between proposed changes, change controls, supporting data, validation packages, and the approved dossier.
• Ensure regulatory submissions present a scientifically sound and internally consistent justification for the proposed change.

6. US FDA Query & Deficiency Management

• Lead regulatory strategy for responding to US FDA information requests, deficiency letters, supplement queries, and other regulatory correspondence.

• Review responses prepared by technical functions to ensure scientific accuracy, regulatory acceptability, consistency with the approved dossier, and responsiveness to FDA questions.

• Coordinate cross-functional response teams and ensure Health Authority responses are submitted within committed or agency-defined timelines.
• Identify high-risk deficiencies and escalate potential impacts on approval, compliance, launch, or supply continuity to senior management.
• Support preparation for teleconferences or meetings with FDA when required.

7. Approval Package Review & Implementation

• Review FDA approval letters and approval packages for post-approval supplements.

• Identify any approval conditions, commitments, limitations, or follow-up requirements.

• Communicate regulatory approval conditions to relevant internal stakeholders.

• Provide regulatory clearance for implementation of approved changes in accordance with the applicable reporting category and internal quality systems.

8. Scientific Advice / FDA Meeting Support

• Support preparation and review of Controlled Correspondence, Pre-ANDA meeting packages, and other FDA meeting or communication packages, where relevant to lifecycle strategy.

• Develop regulatory questions and positions for complex post-approval matters requiring FDA clarification.

• Coordinate technical inputs and ensure the proposed regulatory position is adequately supported by scientific justification.