Senior Regulatory Affairs Leader

Sheemaz
Raza

Regulatory Affairs Manager — MEA & GCC

16+ years driving regulatory strategy across pharmaceuticals, medical devices, and cosmetics in the UAE, GCC, Levant, Egypt, and Iraq. Direct health authority relationships. Proven track record of fastest-in-class approvals.

UAE Golden Visa MOHAP · EDE · SFDA Pharma & Med Devices Dubai, UAE
~80%
Time-to-market reduction — UAE's fastest botulinum toxin approval
16+
Years of regulatory leadership across MEA markets
8
Markets covered — UAE, GCC, Levant, Egypt & Iraq
What I've delivered
Regulatory leadership
with measurable impact

Record Approval Speed

Achieved the UAE's fastest-ever approval for botulinum toxin type A — a biological drug — reducing time-to-market by approximately 80% through strategic health authority engagement.

💼

EDE Repricing Wins

Secured EDE repricing approvals for three blockbuster aesthetics products, directly enabling UAE revenue growth and strengthening commercial positioning.

🗂

Multi-Category Portfolio

Led simultaneous regulatory strategy across pharma, medical device, and cosmetics portfolios — a rare cross-category competency across GCC, Levant, Egypt, and Iraq.

📋

Regulatory QMS Governance

Built and governed end-to-end Regulatory QMS frameworks including SOPs, audit programs, and compliance workflows in multinational environments.

🤝

HCP Compliance Innovation

Implemented innovative compliance software for HCP interactions, resolving cross-functional process gaps and meeting evolving regional regulatory expectations.

🌍

Market Expansion

Supported geo-expansion regulatory submissions across Iraq and Lebanon, identifying early-mover opportunities for blockbuster products in emerging markets.

Areas of strength
Deep expertise.
Rare combination.
  • Regulatory Strategy & Lifecycle Management
  • New Product Registrations (eCTD / CTD)
  • Variation & Post-Approval Change Management
  • Health Authority Engagement & Negotiations
  • Post-Market Surveillance & CAPA
  • Regulatory Intelligence & Risk Management
  • Labeling, Artwork & Promotional Compliance
  • IMDRF / ISO 13485 Medical Device Frameworks
  • Cross-Functional & Regional Team Leadership
  • Regulatory QMS, SOPs & Audit Programs

Direct regulatory relationships with health authorities across the region — a genuine differentiator in multinational markets.

MOHAP
EDE
SFDA
MOH Kuwait
MOH Qatar
MOH Bahrain
MOH Oman
MOH Jordan
MOH Lebanon
MOH Iraq

EDE-licensed Pharmacist-in-Charge · UAE Golden Visa holder

Professional journey
16 years of
regulatory excellence
April 2016 — Present
Regulatory Affairs Manager, MEA-GCC
Galderma Middle East FZ LLC · Dubai, UAE
Led regional regulatory strategy across pharmaceuticals, medical devices, and cosmetics for UAE, GCC, Levant, Egypt, and Iraq. Delivered the UAE's fastest botulinum toxin approval, secured EDE repricing wins, and built cross-functional compliance infrastructure at scale.
January 2014 — February 2016
Regulatory Affairs Associate
Actavis / Allergan · Dubai, UAE
Supported regulatory submissions and lifecycle management across Middle East markets. Contributed to geo-expansion regulatory projects for Iraq and Lebanon. Achieved 89% performance target matrix.
July 2009 — December 2013
Regulatory Affairs Officer
Gulf Pharmaceutical Industries (Julphar) · Ras Al Khaimah, UAE
Managed renewals for over 300 OTC, pharmaceutical, and medical device products in the UAE. Supported third-party and local manufacturing regulatory projects.
Let's connect
Open to senior
leadership roles

I'm actively exploring senior Regulatory Affairs leadership opportunities within multinational companies operating across the GCC and MEA region. If you're looking for a seasoned regulatory leader with direct health authority relationships and a proven track record — I'd welcome a conversation.