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Regional Regulatory Brand Manager - Submissions

Works with DRA GPT (global project team) representative to plan and facilitate presentations to Company regulatory boards on regulatory strategy
Works with DRA GPT representative to interact with regulatory consultants/advisors for global strategic input and challenge
Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with DRA GPT representative
Represents DRA on sub-teams as required HA Interactions
Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents
Develops and implements plans for timely response to HA requests and coordinates responses
Leads rehearsals for HA meetings as appropriate
Implements strategy across regions in line with global strategy Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.
Proposes options to minimize risk
Drives coordination, planning, and submission of dossiers in assigned regions worldwide
Review of global dossier summary documents
Develops and implements plans to avoid/minimize clock stops during submission review
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
Reviews and submits Risk Management Plans
Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative

Excellent verbal and written skills
Knowledge of FDA regulations
Able to work effectively in a matrix team environment
At least 5 years of experience in regulatory affairs

BS in science field; Pharm D preferred
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Renee, CRC

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