Smartedge Solutions
Regulatory Affairs / Global Strategy
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Smartedge’s Client is looking for an individual to help with their Global Regulatory Lead _ on a Contract role in UK / EU (Remote)
Job Summary:
Leading global regulatory strategy for DEUC PsO and PsA program, leading the GRT and leading/executing the US strategy and maintenance work for the IND/NDA
Expected Areas of Competence
- Develop and lead Global and US Regulatory activities for a Development Team(s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.
- Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans
- Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed
- Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders
- Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources
- Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies
- Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
- Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
- Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
- Formulate US regulatory strategy and filings
- Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors
- Approval of regulatory documents
- Ensure documents and regulatory dossier are compiled according to appropriate
- Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.
- Creates a unified and seamless team using both internal and external resources to execute regulatory strategy
- Communicates opinions, facts and thoughts with clarity, transparency and honesty
- Seeks multiple perspectives and listens openly to others’ points of views.
- Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
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Education Required
- Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
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If this sounds like a role you would be interested in or if you know someone in this field. Connect with me or email me at divya.d@smartedgesolutions.co.uk
Alternatively, you can call me on Tel:+44(0)2035002387
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