MEA Regulatory Strategy Director - Accelerate Approvals

Astrazeneca Pharma India Ltd.

United Arab Emirates

On-site

AED 150,000 - 190,000

Full time

4 days ago
Be an early applicant
Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Astrazeneca Pharma India Ltd. seeks a senior regulatory leader to head regulatory affairs for the Middle East and Africa Area (MEA).

You will coordinate with Marketing Companies, global functions, and Area leadership to drive high-quality submissions, accelerated approvals, and fast issue resolution. You will guide policy development, external engagement with authorities and industry groups, and lead cross-functional teams to ensure compliant, timely regulatory decisions that enable patient

Qualifications

  • Degree or equivalent in a scientific field (pharmacy or biological sciences).
  • 10+ years in regulatory drug development with product approvals/launches.

Responsibilities

  • Develop and implement regional regulatory plan to enable rapid approvals.
  • Lead MC Regulatory Heads and global functions in regulatory activities.
  • Define Area policy and advocacy plans with leadership and partners.
  • Engage with health authorities and industry groups to influence pathways.
  • Drive regulatory excellence, compliance, and Good Regulatory Practice.
  • Oversee regulatory interactions with authorities to ensure timely agreements.
  • Provide regulatory leadership for license-in, divestments, and withdrawals.
  • Identify regulatory risks and communicate with senior leadership.
  • Lead digital transformation to improve regulatory speed and consistency.
  • Embed standards and process improvements across regional and global teams.

Skills

Regulatory strategy
Cross-functional leadership
Stakeholder management
Policy & advocacy
Risk management

Education

Degree in pharmacy or biological sciences

Job description

Astrazeneca Pharma India Ltd. seeks a senior regulatory leader to head regulatory affairs for the Middle East and Africa Area (MEA).

You will coordinate with Marketing Companies, global functions, and Area leadership to drive high-quality submissions, accelerated approvals, and fast issue resolution. You will guide policy development, external engagement with authorities and industry groups, and lead cross-functional teams to ensure compliant, timely regulatory decisions that enable patient

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

MEA Regulatory Affairs Director: Strategic Leadership & Growth
MEA Regulatory Affairs Director: Strategic Leadership & Growth

AstraZeneca GmbH • Dubai

On-site
AED 800,000 - 1,200,000
Director, Regulatory Policy & Intelligence – MEA & Eurasia
Director, Regulatory Policy & Intelligence – MEA & Eurasia

AstraZeneca • Dubai

On-site
AED 250,000 - 420,000
Senior Area Regulatory Affairs Director, Middle East, and Africa (MEA)
Senior Area Regulatory Affairs Director, Middle East, and Africa (MEA)

AstraZeneca GmbH • Dubai

On-site
AED 800,000 - 1,200,000
Senior Area Regulatory Affairs Director
Senior Area Regulatory Affairs Director

Astrazeneca Pharma India Ltd. • United Arab Emirates

On-site
AED 150,000 - 190,000
Global Market Access Director – MEA, Asia & LATAM
Global Market Access Director – MEA, Asia & LATAM

AstraZeneca • Dubai

On-site
AED 600,000 - 900,000
Director International Regulatory Policy and Intelligence (International Regulatory Affairs) – [...]
Director International Regulatory Policy and Intelligence (International Regulatory Affairs) – [...]

AstraZeneca • Dubai

On-site
AED 250,000 - 420,000
Regional Medical Strategy Lead — Executive Director
Regional Medical Strategy Lead — Executive Director

Merck Sharp & Dohme Corp • Dubai

On-site
AED 600,000 - 1,200,000
Regulatory Affairs Lead, Gulf Markets
Regulatory Affairs Lead, Gulf Markets

Amgen Inc. (IR) • Dubai

On-site
AED 180,000 - 260,000
Total Rewards Plans
Senior Regulatory Affairs Manager, GCC & KSA
Senior Regulatory Affairs Manager, GCC & KSA

Mundipharma International • Dubai

On-site
AED 360,000 - 540,000
Benefits package
Learning & development
Collaborative environment
+2
VP, Global Compliance for International Markets
VP, Global Compliance for International Markets

AstraZeneca • United Arab Emirates

On-site
AED 900,000 - 1,500,000