Regulatory Affairs Director - Gulf

AstraZeneca

JOB TITLE

Regulatory Affairs Director Gulf

About Astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies.

Role Summary

As the Director of Regulatory Affairs, you provide both strategic and operational regulatory leadership throughout the development, commercialization, and life cycle management of AstraZeneca products in the Gulf markets. You leverage your knowledge of current local and global regulatory trends to anticipate future requirements and develop proactive regulatory strategies. By maintaining regular engagement with regulatory authorities, you effectively influence outcomes to facilitate optimal regulatory approval processes.

You implement initiatives to enhance the quality and efficiency of new submissions and ongoing license maintenance. Throughout the entire product lifecycle, you ensure regulatory compliance, guaranteeing the delivery of high-quality products to market. You also maintain alignment with GRP standards by keeping AZRA systems and portals consistently updated.

Additionally, you support alignment on pricing matters by collaborating with cross-functional teams, ensuring clear communication and consistency in decision-making with Gulf commercial and operations colleagues

Key Responsibilities

• Effective lobbying and influencing with regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in Gulf to support and advise relevant functions
• Provide strategic regulatory advice support for product developments
• Represent AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Provide expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority Regulatory requirements
• Lead and provide regulatory expertise on Gulf regulatory submissions and health authority briefings
• Ensure adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensure all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps.
• Make a significant contribution to product marketing company strategy
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Identify global budget priorities, taking careful note of portfolio growth and business needs
• Identify potential complex regulatory risks to global and regional operational plans, and propose options to mitigate risks
• Communicate all the regulatory updates to the relevant departments to plan for the new products launches accordingly and to assess any impact to the existing products and create mitigation strategies accordingly (if necessary).
• Ensure timely & effective New Drug Application NDA submission and line extensions, License Maintenance and Documentation.
  
  

• Regulatory Strategy: Develops and implements effective regulatory strategies tailored to Gulf countries.
• Local Regulatory Expertise: Demonstrates deep knowledge of Gulf regulatory frameworks, guidelines, and authorities.
• Compliance & Ethical Standards: Ensures all activities comply with local laws, global regulations, and company policies.
• Submission Management: Oversees timely and high-quality product registration, variations, and renewals.
• Stakeholder Engagement: Builds strong relationships with health authorities, distributors, and internal teams.
• Cross-functional Collaboration: Partners with medical, commercial, and legal teams to achieve regulatory objectives.
• Risk Management: Identifies and proactively addresses regulatory risks in new and existing products.
• Process Optimization: Drives continuous improvement in regulatory processes and documentation standards.
• Communication: Provides clear guidance and regulatory updates to internal and external stakeholders.
  
  

• Medical/ Pharmacy/ life sciences degree
• >8 yrs of experience in Regulatory and/or pharmaceutical environment with experience of regulatory drug development, manufacture, commercialization and pricing
• >3 years of successful people management
• Solid understanding of Pharmacoeconomics modelling
• Regulatory & Pricing Strategy Development
• Regulatory Submissions & Approval Management
• Regulatory & Pricing Environment Insight
• Pharmacovigilance Excellence
• Patient Benefit / Risk Assessment
• Quality Management
• Business Relationship Management
• Change Enablement
  
  

• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Significant Regulatory Experience across global projects and regions
• Strong commercial awareness
• Problem solving skills
• Develops collaborative working relationships
• Proactively Innovate and Adapt
• Process Management & Continuous Improvement
• Supplier/Partnership Management
• Audits & Inspections Knowledge