Director of Regulatory Affairs

Strategy Leadership Lifecycle Compliance Training
Strategy Leadership Lifecycle Compliance Training

Career Opportunity

Director of Regulatory Affairs – Saudi Arabia

As Director of Regulatory Affairs, you will define policy, oversee submissions and lifecycle management, train teams, and ensure the organization meets global regulatory standards.

Role Summary

Lead regulatory strategy, eCTD submissions, lifecycle governance, inspection readiness and cross-functional alignment across regulatory, CMC, clinical and quality programs.

Key Responsibilities

  • Define regulatory strategy and policies across programs and regions.
  • Oversee eCTD submissions and lifecycle changes; manage commitments.
  • Build inspection readiness; lead audits and regulatory interactions.
  • Partner with CMC, Clinical, and Quality to de-risk timelines.
  • Develop and train team members on current regulations and SOPs.

Qualifications

  • Master’s or Bachelor’s in a relevant discipline.
  • 12+ years of eCTD submissions and regulatory leadership.

Technical Skills

  • Deep knowledge of global regulations (cGMP/GLP/GCP) and ICH guidelines.
  • Expertise in CMC/labeling variations and post-market surveillance.

Soft Skills

  • Executive communication, stakeholder influence, and people leadership.
  • Structured decision-making and risk management.
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Position Details

  • Location: Saudi Arabia
  • Department: Regulatory Affairs
  • Type: Full-Time
  • Experience: 12+ years
  • Reports To: VP / Head of Regulatory Affairs

Nice to Have

  • Experience with SFDA and at least one major authority (FDA/EMA).
  • Team building in fast-growing organizations.

Frequently Asked Questions

Director of Regulatory Affairs Recruitment FAQs

Governance, team structure, and stakeholder engagement.

End-to-end regulatory lifecycle oversight from development through post-market activities.

Yes—hiring, training, and performance development are core responsibilities.

We align regulatory milestones with portfolio goals in concert with Clinical, CMC, and Commercial leads.