Employee Resource Groups And Take Part
RegulatoryAffairsProjectManager
“Regulatory Affairs Project Manager at Employee Resource Groups And Take Part. Skills: Regulatory affairs, Project management, Biologics. Provide regulatory expertise. Provide project management oversight”
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Bachelor’s or Master’s degree, Extensive experience biologics, Extensive experience cell & gene therapy, Extensive experience ATMPs, Knowledge US FDA, Knowledge EU EMA, Proven experience regulatory submissions, eCTD experience essential, Proficiency Microsoft Word, Proficiency Microsoft Excel, Proficiency Microsoft PowerPoint
Nice to Have
Scientific discipline degree
What You'll Do.
Provide regulatory expertise
Provide project management oversight
Ensure timely project delivery
Author regulatory submissions
Lead regulatory submissions
Manage regulatory submissions
Review regulatory submissions
Support US FDA submissions
Support EU EMA submissions
Support biologics submissions
Support cell & gene therapy submissions
Liaise with regulatory authorities
Support health authority interactions
Develop regulatory strategies
Implement regulatory strategies
Assess impact of changes
Build client relationships
Maintain client relationships
Act as primary point contact
Represent Regulatory Affairs
Communicate technical levels
Communicate scientific levels
Communicate business levels
Manage project deliverables
Manage project timelines
Manage project budgets
Manage financial performance
Contribute to business growth
Identify opportunities
Assist resource planning
Promote right first time culture
Ensure adherence quality standards
Ensure adherence compliance
Ensure adherence continuous improvement
Mentor junior team members
Support junior team members
Contribute team development
Prepare technical documents
Prepare presentations
Share regulatory updates
How You'll Work.
Team & Collaboration
Internal meetings; Client meetings; Agency meetings; Cross-functional teams
Communication Scope
Written communication; Verbal communication; Technical communication; Scientific communication; Business communication
Process & Methodology
Project management, Timeline management, Budget management
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