Summary : Seeking a Regulatory Affairs Project Manager with expertise in pharmaceutical industry submissions, project management, and regulatory electronic submission software.
Requirements :
Bachelor's Degree in a technical discipline, pharmaceutical industry, or related life science
Certification in Project Management preferred
Minimum 3 years of Regulatory Affairs experience supporting submission content, compilation, or publishing
Minimum 3 years of Project Management experience in the Pharmaceutical or Health-related industry
Preferred Skills :
Proficiency in managing project submissions within established timeframes
Experience with regulatory electronic submission software
Ability to manage multiple projects and priorities effectively
Responsibilities :
Manage project submissions as directed by Regulatory Affairs leadership, ensuring adherence to department work processes
Plan and execute key projects for submission, approval, and launch while maintaining timing and execution standards
Maintain a project database to track individual and departmental project deliverables
Handle incoming requests by logging, assigning, tracking difficulty and complexity alongside RA staff
Keep up-to-date with department metrics through database maintenance and tracking of key deliverables
Utilize regulatory electronic submission software to streamline the compilation process efficiently
Collaborate closely with RA staff on assigned projects to mitigate resource conflicts and manage competing priorities
Pay Details : $60,000.00 to $65,000.00 per year
Equal Opportunity Employer / Veterans / Disabled
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