Transition Regulatory Lead (TRL)

Overview:
Business partner responsible for driving and overseeing the life cycle transitions of assets across the Regulatory organization. This role expertly leads cross-functional Regulatory plans and executes asset transition strategies, and ensures effective project delivery, compliance with regulatory requirements, and alignment with business needs by:

Planning & directing the seamless Regulatory execution of asset transition objectives through all stages of an asset’s lifecycle (due diligence through full transition)
Expertly leading cross-functional Regulatory teams to deliver successful transition outcomes by providing expert and effective project management planning, leadership, direction, and oversight (partnering with Global Regulatory Leads [GRLs], Regulatory Project Managers [RPMs], GRA-CMC, and LOC-RA where applicable)
Assigning and overseeing Regulatory operational support provided by internal and/or external staff.

Details:
Project Leadership & Governance

Partner with other R&D; functions (clinical operations, pharmacovigilance,



program management, finance, IT) as well as other business units (Quality, Supply Chain, GMS, Global BD, Commercial, and Legal) and global, regional, and LOC Regulatory Affairs to develop and implement detailed cross-functional Regulatory transition plans for asset transitions
Lead cross-functional Regulatory teams to achieve asset transition milestones and objectives
Engage senior leadership to ensure project alignment and appropriate identification and management of Regulatory’s asset transition risk.

Stakeholder Engagement
Act as the primary GRA liaison for stakeholders regarding asset transitions
Liaise with global, regional, and LOC Regulatory functions and external parties to ensure coordination of strategic and tactical Regulatory planning and execution
Provide clear communication and status updates to internal and external stakeholders

Process Improvement
Contribute to the continuo

📌 Transition Regulatory Lead (India)
🏢 Freyr Solutions
📍 India