About the job

Smartedge's Client is looking for an individual to help with their in Global Regulatory Lead _ Contract _ UK / EU (Remote)

Global Regulatory Lead (GRL) US Regulatory Lead (USRL) reg strategy lead experience·       Expert in global and US regulatory activities, assessing risk and driving HA interactions.·       Expert in psoriasis and psoriatic arthritis. Drug will be Deucravacitinib or DeUC program·       Two rounds of interview will be conducted. One with hiring manager and other with GBS panelists·       Previously served as USRL (FDA point of contact and facilitated meetings) and GRL·       Significant experience in regulatory affairs (e.g. > 4-7 years)

Job Description :

·       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·       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·       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 standard and guidelines Behaviours·       Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.·       Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting·       Generates alternative regulatory strategies and plans, and assesses benefits and risks.·       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.·       Demonstrates ownership of results within (and beyond) area of responsibility.·       Sets clear and high expectations and holds self and others accountable for decisions and results achieved.·       Develops and applies unique ideas and new methods to achieve higher performance and excellence.·       Works across organizational, functional and geographic boundaries to achieve company goals.·       Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.·       Demonstrates resilience and perseverance.

Connect with my Colleague or email my Colleague at pavithradevi.r@smartedgesolutions.co.uk

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