Regulatory Affairs Project Manager

Entegee
Noblesville, Indiana
$60K-$65K a year
Full-time

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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30+ days ago
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