Regulatory Affairs Specialist

eCTD Compliance cGMP GLP GCP
eCTD Compliance cGMP GLP GCP

Career Opportunity

Regulatory Affairs Specialist – eCTD & Lifecycle Submissions

As a Regulatory Affairs Specialist, you’ll manage eCTD submissions, maintain compliance, and work cross-functionally to ensure products meet global regulatory requirements.

Role Summary

Prepare and maintain regulatory dossiers, coordinate cross-functional submission content, support health-authority responses and manage product-registration lifecycle activities.

Key Responsibilities

  • Compile and submit eCTD sequences for new and lifecycle applications.
  • Coordinate cross-functional inputs and ensure dossier quality and readiness.
  • Maintain regulatory databases, registrations, and post-approval changes.
  • Monitor regulations/guidelines and advise teams on impact and actions.
  • Support health authority Q&A and inspections; maintain inspection readiness.

Qualifications

  • Master’s or Bachelor’s in Chemistry, Biology, or Pharmaceutical Sciences.
  • 5+ years hands-on eCTD submission experience.

Technical Skills

  • Knowledge of ICH/CTD structure; publishing tools; labeling/CMC modules.
  • Strong grasp of cGMP/GLP/GCP and change control.

Soft Skills

  • Meticulous attention to detail; documentation discipline.
  • Clear communication with cross-functional stakeholders.
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Position Details

  • Location: Saudi Arabia
  • Department: Regulatory Affairs
  • Type: Full-Time
  • Experience: 5+ years
  • Reports To: Regulatory Affairs Manager

Nice to Have

  • Direct agency interaction (e.g., SFDA/FDA/EMA).
  • Labeling management and artwork control experience.

Frequently Asked Questions

Regulatory Affairs Specialist Recruitment FAQs

Submissions, timelines, and collaboration with CMC/QA.

Primarily KSA and regional markets; global submissions based on program needs.

Standard eCTD compilation/publishing suites compliant with ICH specifications.

Yes—supporting queries, meetings, and commitments with relevant health authorities.