Clinical Regulatory Project Manager - REMOTE

King of Prussia, PA 19406

Posted: 01/11/2019 Industry: Other Area(s) Job Number: 33212

Clinical Regulatory Project Manager - REMOTE

This role requires Operational Submission experience; Project Management Experience;  Regulatory Affairs and Pharma background.  This role can navigate MS project and manage meetings.   The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. 

Requirements

• Relevant University Degree in Science or related discipline

• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

• General knowledge of drug development

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

 • Regulatory experience

• Managed regulatory deliverables at the project level

• Thorough knowledge of the drug development process

• Proficiency with common project management (e.g., MS Project) and document management tools

• Ability to analyze problems and recommend actions • Continuous Improvement and knowledge sharing focused Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs) • Regional Leads (eg, US, EU international RADs)

• Lead RPM • Other GRAPSQA skill groups, eg, GRO, GLG, Reg CMC, CMC RC, PS

• Other Science Unit functions within the IMED and GMED • Operations (CMC post approval)

• Marketing Companies • Health Authorities • External collaboration partners
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