Freyr Solutions
Website:
freyrsolutions.com
Job details:
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 efficient 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 continuous improvement of processes and best practices required to ensure Regulatory’s efficient and effective asset transitions
- Ensure Regulatory’s transition processes maintain compliance with relevant Regulatory requirements and internal standards.
Strategic Planning & Demand Management
- Create, lead, and deliver actionable assessment reports and updates, as well as efficient processes for Regulatory’s asset transition portfolio status reviews
- Develop, implement, and oversee operational support requirements for Regulatory’s asset transitions, including, but not limited to, regulatory data transfers and change controls
- Identify potential Regulatory asset transition risks and develop & implement mitigation strategies to address, escalating as necessary through project Governance framework
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree in Life Sciences, Business Administration, or related field (Advanced degree preferred)
- 10+ years of experience in the pharmaceutical and/or biotech industry
- 7+ years of experience in Regulatory Affairs or drug development project management
- Expert at defining requirements, planning, and executing country-level Marketing Authorization Transfer (MAT) submissions and approvals (experience across Asia/ME markets preferred)
- Prior experience supporting divestments required. Experience supporting acquisitions/integrations preferred.
- Familiarity with regulatory systems, compliance frameworks, and quality control
- Strong communication, stakeholder management, and strategic planning skills
Click on Apply to know more.
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