The CMC Regulatory Sciences Coordinator is responsible for coordinating and supporting the deliverables and continuous improvement projects of the CMC Regulatory Sciences department to ensure timelines are met, potential resource constraints are anticipated, and changes in the expectations of regulatory authorities are incorporated into the business.

As a CMC Regulatory Sciences Coordinator, a typical day might include the following :

Program tracking :

Tracks the due dates for Specialist deliverables to help identify resource constraints before they result in slipping timelines.

Coordinates the initiation of regulatory submission document reviews (e.g., cross-functional reviews and copyediting / data verification reviews with the CMC-RS Document Quality group.

Provides submission coordination support :

Initiates SharePoint workflows.

Updates batch analysis tables as new lots are dispositioned.

Formats submission sections (e.g., stability and batch analysis tables).

With guidance / oversight of specialists, organizes the product SharePoint folders into a consistent scheme with improved navigability.

Tracks ex-US commercial filings completed by partners.

Creates / maintains content trackers for regulatory submissions for assigned programs.

Keeps management and others informed on progress of CMC-RS deliverables for assigned programs.

Department support :

Coordinates validation protocol and report reviews.

May oversee projects and assign projects to other coordinators.

This role may be for you if :

You have excellent written and verbal communication skills.

You have the ability to prioritize, coordinate, and complete multiple projects within deadline under minimal supervision, while maintaining a high level of attention to detail is a must.

You exhibit strong skills in planning, critical thinking, and problem-solving.

In order to be considered for this position, you must have the following :

Requires Associates degree and 2 years of relevant experience or equivalent combination of education and experience; Bachelor’s degree preferred.

Project management experience preferred.

Strong experience creating and maintaining reports, specifically with MS Word and Excel.

Last updated : 2024-07-01