CMC Submission Specialist - Warren, NJ

This role is critical to ensuring accurate, timely, and compliant submissions for multiple pharmaceutical brands. · ...

The position of Electronic Submission Specialist involves supporting the coordination, preparation, and submission of regulatory dossier submissions to Health Authorities. · Support Global Regulatory Operations Leads in the coordination... · ...

Job summary:The Electronic Submission Specialist will support Regulatory Affairs personnel in coordinating, preparing, and submitting regulatory documents.Key responsibilities include creating quality submissions, maintaining archives, verifying regulated documents via workflows ...

Job summary · The contractor will provide CMC Submission support focused on the compilation, · assembly, and quality control (QC) of CMC content for regulatory submissions.Reporting to the Regulatory Affairs lead, · this role contributes to preparing submission-ready CMC modules, ...

The Associate, Regulatory Affairs Submission Management manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. · ...

We are seeking a Product Data Specialist who will manage item and material data throughout its lifecycle. The ideal candidate will own the process of submitting and tracking items, resolving issues that pop up and making sure everything fits together just right. · Management and ...

Seeking a Product Data Specialist who's great at turning ideas into finished products by managing item and material data throughout its lifecycle. You'll own the process-from submitting and tracking items to resolving any issues that pop up-making sure everything fits together ju ...

The Manufacturing Director of EHS and HR oversees a team supporting · EHS/HR functions across six manufacturing facilities in North America. · Create a clear EHS and HR strategic vision aligned with manufacturing goals. · ...

We're looking for a Customer Relations Specialist to join our PSA Vault Customer Relations team.Professional Sports Authenticator (PSA) is the largest and most trusted third-party trading card authentication and grading company in the world. · ...

We are looking for a Customer Relations Specialist to join our PSA Vault Customer Relations team. · Facilitate communication between Vault Customer Care and operational teams regarding damaged inventory items. · Utilize Salesforce work order management system to coordinate resolu ...

Key Responsibilities · Prepare CMC sections of BLA · Execute regulatory submission activities using Veeva Vault RIM/Docs · Ensure compliance with FDA ICH and eCTD standards Track document readiness manage timelines and resolve submission issues Support FDA information requests am ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, · compliance and submission of digital promotional materials within the Veeva platform.This role ensures all content is accurately anchored · version-controlled and submission-rea ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, · ensure all content is accurately anchored,version-controlled and submission-ready, · serving as a critical bridge between marketing, regulatory, medical, legal writers and desig ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, compliance, and submission of digital promotional materials within the Veeva platform. · translate RC and MLR feedback into clear, actionable guidance · conduct comprehensive end- ...

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Content Quality & Submission Lead for a 10-month contract with the possibility to extend. · ...

We are seeking a detail-oriented Content Quality & Submission Lead (Veeva Specialist) to manage the end-to-end quality, compliance, and submission of digital promotional materials within the Veeva platform. · ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, compliance, and submission of digital promotional materials within the Veeva platform. · This role ensures all content is accurately anchored, version-controlled, and submission-r ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, compliance, and submission of digital promotional materials within the Veeva platform. · ...

We are seeking an experienced CMC Submission Specialist to support the preparation, · management and execution of Chemistry Manufacturing and Controls components for an upcoming Biologics License Application BLA. · ...

We are seeking a detail-oriented Content Quality & Submission Lead to manage the end-to-end quality, · compliance, and submission of digital promotional materials within the Veeva platform.Translate RC and MLR feedback into clear, · Conduct comprehensive end-to-end quality contro ...