Global Development Regulatory Lead

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/NDAExpected

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.

Education Required

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

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 [email protected]

Alternatively, you can call me on Tel:+44(0)2035002387