Senior Manager, Regulatory Document Management - REMOTE job in Willow Grove, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

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Phone Number*

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Job type: Permanent

Discipline: Medical Communications, Medical Writing, Project Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Senior Manager of Regulatory Document Management with an international biotech company. As a document management lead, you will oversee the technical quality of regulatory documents ensure their submission readiness, and drive the document compilation/adherence process.

Job Responsibilities:

Responsible for providing submission management and Publishing for BLAs, INDs, and CTAs applications.
Responsible for interfacing with project managers, regulatory leaders, and/or content authors to discuss planned submission preparation.
Identifies regulatory risks and emerging issues and proactively develops mitigations and solutions.
Ensures that all regulatory content and information is appropriately tracked, archived, searchable, and accessible via Document Management System.
Responsible for the creation, assembly, and publishing of routine eCTD submissions for IND and BLA applications.
Efficient at producing high-quality graphics for inclusion in protocols, CSRs, IBs, etc.
Adherence to required submission timelines, health authority publishing specifications, and internal working practices.

Skills and Requirements:

4+ years in pharma/biotech space
Good understanding of regulatory requirements and drug development processes, GCP/GXP, and guidelines associated with regulatory documents.

If you are having difficulty in applying or if you have any questions, please contact Trajan Susa-Coelho at (+1) 858-727-2330 or t.susa-coelho@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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