Regulatory Document Specialist

1 day ago


Mississauga, Ontario, Canada GlaxoSmithKline Full time

Job Summary

We are seeking an experienced Regulatory Document Specialist to join our team at GlaxoSmithKline. The successful candidate will be responsible for drafting, reviewing, and approving written assignments, including marketing application submission documents.

About the Role

This is a unique opportunity to work with a talented team of experts in clinical trial design and interpretation of statistically analyzed research data. As a Regulatory Document Specialist, you will drive and coordinate the process to draft, review, and approve written assignments, demonstrating your expertise in clinical document development and regulatory compliance.

Key Responsibilities

  • Draft, review, and approve complex regulatory documents, including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Work collaboratively with cross-functional teams to ensure delivery of high-quality, fit-for-purpose clinical documents that accurately reflect associated data and meet GSK standards and global, regional, and/or local regulatory requirements.
  • Contribute to the planning and production of clinical dossier documents for regulatory submissions worldwide, leveraging your expertise in clinical pharmacology, biomarkers, health outcomes, and statistical analysis.
  • Develop effective plans for solutions, assess complex situations, and apply scientific, operational, and submission development knowledge.
  • Maintain high-level technical, statistical, and computer skills, with the ability to interpret complex clinical data, assess trends and patterns, and effectively organize content and messages in clinical reports and summary documents.
  • Review reporting and analysis plans, provide critical input on content and display of tables, and stay up-to-date with approaches to expedite document preparation, such as review tools and automation.

Required Qualifications

  • PhD or relevant working experience within the life sciences space.
  • Clinical regulatory writing experience in the pharmaceutical industry.
  • Demonstration of leadership, experience in multicultural settings, and ability to interpret, describe, and document clinical data.
  • Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP) and excellent English language skills (verbal and written).
  • Computer skills and general computer literacy.

What We Offer

We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus benefits, including medical, dental, and vision insurance, 401(k) matching, and paid time off. If you are a motivated and detail-oriented professional with a passion for clinical document development and regulatory compliance, we encourage you to apply.



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