Job Description

This position is REMOTE (candidate should currently reside on East Coast)
Based out of New Brunswick NJ

Job Description:

• Manage document preparation of CMC regulatory submission documents to Client standards and ensure final document compliance to ensure submission content meets formatting requirements.
• Manage the logistical process in the authoring system for CMC regulatory submissions.
• This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams.
• Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
• Author CMC elements of regulatory filings with supervision.
• Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.

Education and Experience Required:

• Bachelor’s degree in a relevant discipline with a minimum of 3-5 years’ relevant experience. Master’s degree with 0-2 years’ relevant experience.
• Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
• Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
• Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
• Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.

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