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Aequor · 1 month ago

CMC Regulatory Technical Writer II

Morristown, NJ

Full-time

Hybrid

Mid, Senior Level

5+ years exp

Aequor is seeking a CMC Regulatory Technical Writer II to join their CMC Dossier Development team. The role involves collaborating with global business units to develop and author regulatory documents and ensure compliance with CMC regulations.

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 manufacturingInterpersonal communicationSelf-motivatedAttention to detail

Required

3-5 years of experience

Authoring experience (Modules 2 and 3)

Ability to work independently

CMC regulations/scientific background is required

MS Office

Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3)

The candidate must have at least 5 years' experience in the pharmaceutical industry

Excellent interpersonal communication skills are required

Knowledge of US pharmaceutical Regulations is essential

The candidate needs very little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated

BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field)