CMC Regulatory Affairs - Biologics / Biosimilars

Primary Responsibilities :

• Responsible for finalizing the CMC regulatory strategies for assigned products (Biological products) and provide support to execute tasks independently in accordance with global regulations and guidance procedures.
• Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems.
• Lead the Change control evaluation, preparation, and submission of CMC dossiers for life-cycle changes to commercial products in support of project execution.
• Lead & plan the bundling / grouping strategy of variations and geo-expansion strategy of active Marketed products.
• Aid in the development and Lead execution of global product and project regulatory strategy(s) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
• Provide regulatory leadership as needed to product in-license / due diligence review, product divestment and product withdrawal.
• Collaborate with internal and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Manage execution of CMC documentation including complex post-approval variations, registration renewals and responses to health authority questions per established business processes and systems.
• Demonstrate a robust understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
• Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate, and escalate potential regulatory issues to management, as needed.
• Demonstrate ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrate flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrate effective leadership, communication, interpersonal and negotiating skills in the most complex and fast-paced team environments.

Experience required :