Regulatory Submission Project Management Specialist

Tarrytown, NY 10591

Posted: 06/05/2019 Industry: Biotech/R&D/Science Job Number: 48998

Regulatory Submission Project Management Specialist 

 

Summary:

Responsible for project management of Regulatory submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

Requires some guidance from direct manager.

Provides support and backup to management as needed.


Job Duties:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

Creates and manages Submission Plans (Table of Contents, timelines, and responsibility matrices)

Coordinates submission documents (routing documents for review, uploading into the EDMS and preparing approvers for upcoming approval tasks) and prepares and manages submission binders

Conducts kickoff and other cross-functional meetings related to submissions, such as IND working group meetings related to briefing books, IND responsibilities review, IB kickoff, document review resolution discussions

Negotiates the resolution of submission timeline conflicts with other project managers in preclinical and clinical to align timelines for deliverables feeding into the regulatory timeline

Provides requested submission documents to partners and CROs

Maintains and tracks regulatory commitments and reoccurring submission obligations, such as 6-month distribution reports, annual establishment registration and annual reports

Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance

Assists with regulatory inspection activities

Identifies and communicates regulatory system enhancement needs or technical issues to management and CDRA Systems

Provides guidance on good documentation and submission practices


Requirements:

Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

Requires eCTD knowledge.

Project management skills strongly desired.

Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize and work well with others, works effectively under pressure, and has excellent written and verbal communication skills.

Strong knowledge with MS Office applications and Adobe Acrobat is required. Strong knowledge with MS Project and electronic document management systems (eg, Veeva, and SharePoint ) is desirable.

5-7 years

Victoria Gatarz

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