CMC Regulatory Affairs Specialist

2 weeks ago

Bridgewater, United States Spectraforce Technologies Inc Full time

Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri

Pay Rate starts: $47/ HOUR

HM Notes:

  • Hybrid - onsite Tuesday & Thursday - This can change at any time.
  • 5 years experience with scientific background (BA/BS, MS or PhD)
  • Must have experience with CTD (Common Technical Document) modules.
  • Will complete regulatory submissions, compliance, and amendments.
  • Expert in Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus



Description:
The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she coordinates directly with key stakeholders within industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners).

Key Responsibilities:
The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners. He/She identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
He/she authors autonomously the CMC sections of dossiers using templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards. He/She ensures delivery of sections in a timely manner.
He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
He/she performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
He/She maintains an up to date knowledge of ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
He/She also authors other types of regulatory documents such as white papers, position papers, and briefing book.
In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.


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