Regulatory Affairs Specialist - HCM

Maintain in-depth knowledge of key product-related areas, including commercial strategy, dossier content, regulatory intelligence, regulatory timelines, and supply strategy.

Develop and implement milestone plans for drug registrations.

Prepare high-quality regulatory submissions and manage product registrations for new applications, license extensions, and variations.

Develop packaging artwork to support new product launches and lifecycle management.

Provide detailed updates on the regulatory status of impacted products and advise on appropriate regulatory pathways and processes.

Maintain regulatory compliance databases and associated processes.

Monitor registration activities to ensure timely submission and approval of new product registrations, license extensions, and regulatory changes, aligned with company strategic business goals.

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