Sandoz
Healthcare
RAManager
“RA Manager at Sandoz. Skills: Regulatory affairs, Compliance, Submissions, Approvals. Participate in Global RA project meetings. Provide input into global strategy”
What You'll Achieve.
Successful implementation of regulatory strategy; Timely submissions; Timely approvals; Adherence to Sandoz policy; Adherence to Sandoz guidelines
Industry & Context.
Analytical thinking; Proactive approach; Problem-solving; Evaluate regulatory requirements; Troubleshoot issues; Risk mitigation; Decision making
Authorized to work in U.S., Up to 5% travel
What They're Looking For.
Must Have
Bachelor in science, 3-5 years regulatory affairs, Knowledge of industry trends, Understanding of FDA regulations, Understanding of EMA regulations, Understanding of MHRA regulations, Proficiency in data analysis, Proficiency in regulatory document preparation, Experience with HA meetings, Experience with HA communications, Fluent English
Nice to Have
Ability to work independently, Ability to work under pressure, Demonstrating initiative, Flexibility, Team spirit, Embracing diversity
What You'll Do.
Participate in Global RA project meetings
Provide input into global strategy
Implement agreed upon strategies
Prepare US eCTD documents
Facilitate timely submissions
Manage regulatory documents
Track regulatory activities
Maintain regulatory archive systems
Support local regulatory requirements
Prepare annual reports
Determine HA interaction requirements
Set HA interaction objectives
Coordinate regulatory information
Participate in launch preparation
Execute operational activities
Manage operational activities
How You'll Work.
Team & Collaboration
Global RA project meetings; Various project teams; Cross functional meetings
Communication Scope
Verbal communication; Written communication; Clarity; Confidence
Process & Methodology
Project management, Portfolio management
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