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Aequor · 1 month ago

CMC Regulatory Technical Writer II

Morristown, NJ

Full-time

Hybrid

Mid, Senior Level

3+ years exp

Aequor is a company seeking a CMC Regulatory Technical Writer II to join their CMC Dossier Development team. The role involves developing and authoring chemistry, manufacturing, and controls (CMC) technical documents for regulatory dossiers, collaborating with global business units, and ensuring compliance with regulatory guidelines.

ConsultingIT ManagementRecruiting

Responsibilities

The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines

This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports

Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs

The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:

Following regulatory guidelines, source documentation, and ***'s templates

Collaborating and coordinating with key stakeholders across the GBU's, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)

Avoiding unsolicited regulatory burden

Supporting the development of regulatory risk mitigation strategies

Maintaining up-to-date knowledge of ***'s ways of working, SOPs, and CMC regulations and guidelines

Supporting the planning and preparation of timelines

Qualification

CMC regulationsCTD authoringMS OfficeVeevaDocumentumPharmaceutical industry experienceInterpersonal communicationIndependent workAttention to detailSelf-motivated