Assistant Manager& Deputy Manager Regulatory Affairs (Query Handlin

Key Responsibilities

Regulatory Documentation & Dossier Management

• Coordinate collection of documents for customer due diligence, technical dossiers, renewals, post-approval changes, and lifecycle management.
• Review dossiers prepared by the team, perform GAP analysis, ensure corrections, and finalize regulatory data packages for submission to MOH, country managers, business partners, or service providers.
• Handle ORF/DRF activities including dossier due diligence, planning, data availability assessment, and finalizing timelines as per regulatory guidelines.

Site Registration & Licensing

• Receive site registration requirements from business partners, territory agents, or BD teams.
• Coordinate with internal and external stakeholders for site registration document collection and submission.
• Ensure validity and availability of licenses including Manufacturing License, FSC, WHO GMP, Local GMP, COPP, Brand Name License, etc.

Artwork, Labeling & Regulatory Compliance

• Prepare and review artwork, SmPC, and package inserts in alignment with reference products and respective MOH guidelines.
• Maintain regulatory trackers and status reports covering new registrations, renewals, re-registrations, variations, and post-approval changes.

Query & Variation Management

• Receive and assess regulatory queries from customers and MOHs.
• Design responses, coordinate document collection, finalize submissions, and ensure timely closure.
• Maintain and update variation trackers, allocate compilation activities, review data packages, and ensure compliant submissions.

QMS & Safety Reporting

• Review Periodic Safety Update Reports (PSURs) and provide regulatory inputs for APQR and other QMS documents.
• Assess and approve QMS documents such as work orders, change controls, bulk transfers, and OOS notifications.

Planning, Reporting & Database Management

• Execute daily, weekly, monthly, quarterly, and annual regulatory planners for Regulated and ROW markets.
• Prepare management reports, monthly trackers, payment invoices, and regulatory activity summaries.
• Manage electronic regulatory databases and folder structures for data integrity and traceability.

Training & Regulatory Intelligence

• Circulate and provide training on new or revised regulatory guidelines issued by various MOHs.
• Train internal teams on regulatory processes and compliance requirements.

Strategic & Client Coordination

• Contribute to regulatory strategies for new product approvals, line extensions, and lifecycle management, including EU markets.
• Participate in client meetings and ensure compliance with agreed action items.
• Initiate and coordinate scientific advice meetings with territory agents, partners, or MOHs regarding submission strategies and regulatory requirements.

Additional Responsibilities

• Support registration sample preparation in coordination with R&D, QA, and other stakeholders.
• Perform miscellaneous regulatory affairs tasks as assigned by the reporting manager or Head.

Share cv at :- NeetiJ@selectsourceintl.com