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Remote Regulatory Specialist

Company: Global Channel Management,Inc
Location: Greenwood
Posted on: November 22, 2021

Job Description:

Remote Regulatory Specialist needs demonstrated knowledge of post-approval Chemistry, Manufacturing and Control (CMC), including submission planning and tracking
Remote Regulatory Specialist requires:
Knowledge and understanding of ICH requirements regarding CTD formatting
Proficiency in eCTD systems and format
Strong computer skills with proficiency in Microsoft Office applications
Proficiency in SharePoint
Proven ability to take initiative and identify opportunities to contribute to product and process improvements
Self-motivated individual with demonstrated ability to identify issues and solutions for a positive result
Demonstrated analytical thinking and problem solving skills
Proven strong written and verbal communication skills
Demonstrated capability to track numerous communications and ensure timely response and completion of deliverable
Flexibility and ability to handle time pressures
Ability to prioritize workload and organize accordingly
Effective interpersonal skills; can work as part of a team

Remote Regulatory Specialist duties:
Support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance.

Keywords: Global Channel Management,Inc, Greenwood , Remote Regulatory Specialist, Other , Greenwood, Indiana

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