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Manager, Regulatory Affairs (Operations)

11 hours, 56 minutes ago
United States
Full-time
Senior
Operations Manager
Operations
Apply Now
Telix Pharmaceuticals

Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical firm dedicated to the development and commercialization of diagnostic and therapeutic products that utilize targeted radiation, aiming to enhance treatment decisions and provide personalized therapies...

Pharmaceuticals
201-500
Founded 2015
View All Jobs 32

Description

  • Guide cross-functional teams on regulatory requirements for compliant submission documents and manage document workflows.
  • Manage document-preparation timelines and deliverables across the product portfolio in line with submission plans.
  • Prepare, format, quality-check, and finalize regulatory documents for eCTD submission readiness.
  • Use regulatory operations tools and publishing systems to meet company and health-authority document standards.
  • Maintain and support RIMS and EDMS platforms, including Veeva Submission and Archive Vaults.
  • Develop and maintain templates, style guides, procedures, and standards for authoring, review, formatting, and publishing.
  • Provide document best-practice guidance, troubleshooting, and training to internal teams.
  • Drive process improvements and quality standards for regulatory submission document preparation.
  • Support Health Authority portal submissions, RA SOW/PO administration, and leadership metric reporting.

Requirements

  • Bachelor's degree or equivalent experience.
  • 7+ years of Regulatory Affairs Operations experience.
  • Experience with US/Canadian and/or European regulatory legislation and procedures.
  • Experience formatting, quality-checking, and finalizing documents for eCTD submissions, including NDAs and/or EU Marketing Authorization Applications.
  • Expert knowledge of CTD/eCTD structure, formatting, and submission requirements, including systems such as Lorenz docuBridge.
  • Experience with MS Word authoring templates, Adobe Acrobat, electronic publishing software, and document management systems such as CSC Toolbox and Veeva Collaborative Authoring.
  • Strong project management and organizational skills, with the ability to manage multiple projects and tight deadlines.
  • Excellent attention to detail, written and verbal communication, and ability to work with internal teams and external vendors.
  • Ability to work independently in a remote, multi-time-zone environment and collaborate across functions, locations, and cultures.
  • Fluent English communication skills; an additional European language and understanding of dossier lifecycle management are preferred.

Benefits

  • Competitive salary.
  • Annual performance-based bonus.
  • Equity-based incentive program.
  • Generous vacation time.
  • Paid wellness days.
  • Learning and development support.
  • Hybrid and remote work opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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