Regulatory Affairs Consultant (Hybrid)

Overview

ClinChoice is searching for a Regulatory Affairs Consultant till Dec’2025 with (possibility of extension into 2026) to join one of our clients. Hybrid Model : 2 days a week.

Responsibilities

• Preparation, compilation, and coordination of high-quality regulatory submissions for new product launches, product updates, and throughout product lifecycle.
• Ensure that documents to be submitted to health authorities are ready by ensuring quality review is performed before forwarding to client regulatory personnel.
• Research, draft and assemble the documents required to secure export certificates, market specific product applications / notification and health authority clearances
• Review of artwork changes and associated change controls, including tracking of deliverables.
• Monitoring of new and changing regulatory standards and dissemination of information.
• Support coordination of label change initiation, label reviews and changes in accordance with regional / country review system and procedure.
• Provide regulatory input, review and approval related to change control
• Support product portfolio through execution of legal document activities as required
• Coordination with cross functional teams, manufacturing site and local affiliates for the required information to process the documents
• Search different internal tools for the required information to process the documents.
• Develop and manage regulatory action item tables for country specific requirements
• Mapping, coordination of regulatory inputs and timing end to end for country requirements resulting from legal entity change e.g., documentation required, timelines for registrations / notifications and phase-in of changes to meet compliance requirements
• Communicate internally and monitoring deliverables ensuring country requirements are met by specified timeframes
• Record and publish meeting notes. Incorporate follow-up items to project deliverable tracking, ongoing monitoring, and issue escalation to client local managers.
• Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing
• Work with client regulatory managers to develop project implementation plans
• Support client regulatory managers in their registration procedure
• Complete market impact assessments
• Generation of databases and checklists for project monitoring
• Support in the creation of product history and archives
• Company systems update
• Provision of weekly updates (at a minimum) to relevant client regulatory managers
• Ensure regulatory standards and timelines are met
• Plan and track the status of ongoing regulatory projects
• Regulatory action item tables for country specific requirements and importation / exportation needs for change in legal entity
• Presentation materials for management updates
• Ensuring documents for health authority are submission-ready
• Supporting coordination of label change initiation, label reviews and changes in accordance with regional / country review system and procedure.
• Regulatory input, review and approval related to Change Control

Experience / Qualifications

Seniority level

Employment type

Job function

Industries

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