Regulatory Affairs Lead

About AstraZeneca

AstraZeneca is a global biopharmaceutical organization devoted to the discovery, development, and commercialization of prescription medicines targeting serious diseases. Beyond being a leading pharmaceutical entity, the company is dedicated to advancing healthcare worldwide.

Site Overview

The company is undergoing a substantial transformation in Saudi Arabia, emphasizing healthcare innovation and sustainable growth aligned with Saudi Vision 2030. Investments in talent, digital solutions, and adaptive working practices aim to improve patient outcomes and bolster AstraZeneca's leadership in therapeutic fields.

Role Summary

The Regulatory Affairs Lead will spearhead regulatory strategies and manage submissions throughout the product lifecycle, ensuring adherence to both local and international standards. This position offers expert guidance on regulatory processes, proactively addresses risks, and collaborates with health authorities and internal teams to facilitate timely access to innovative treatments. Reporting to the Regulatory Affairs & Pricing Director, the role supports the RA governance framework.

Key Responsibilities

• Lead and coordinate cross-functional teams in managing complex global regulatory submissions, maintaining AstraZeneca’s compliance standards.
• Offer strategic regulatory expertise to product and project teams, anticipating requirements from health authorities.
• Identify and mitigate regulatory risks affecting operational plans at both global and regional levels.
• Enhance submission quality, efficiency, and timeliness through implementation of effective strategies.
• Oversee product licensing, registration, and post-marketing obligations including labeling, safety reporting, inspections, and audits.
• Serve as the principal regulatory liaison with key authorities such as SFDA and GHC, ensuring updates to global regulatory systems.
• Collaborate with business units and internal stakeholders to support country-specific regulatory priorities.
• Engage with local agents' regulatory teams regularly to align activities and ensure execution.
• Facilitate alignment among therapy area RA managers, local agents, and global stakeholders on regulatory objectives.
• Represent AstraZeneca’s regulatory stance in official interactions with authorities and industry forums.
• Manage and mentor a small regulatory team, setting goals, coaching, and providing development opportunities.
• Cultivate a culture of teamwork, innovation, and courageous leadership within regulatory teams.
• Participate in and lead critical projects to integrate regulatory needs into organizational processes and standards.
• Establish and nurture relationships with Regulatory Health Authorities, industry groups, and external partners.
• Stay abreast of changes in regulatory policies and industry trends, communicating impacts internally.
• Support business development activities including proposal development, reporting, costing, and budgeting aligned with corporate strategy.
• Ensure all regulatory activities adhere to AstraZeneca’s ethical code, corporate policies, and local laws.
• Promptly report adverse events, compliance issues, conflicts of interest, and environmental or health incidents.
• Contribute regulatory insight for audits, inspections, recalls, and related communications to minimize risk.

Additional Details

Only candidates residing in Saudi Arabia will be considered. AstraZeneca is committed to fostering an inclusive and diverse work environment and adheres to all relevant non-discrimination statutes.

Candidate Requirements

• Saudi national status required.
• Academic background in pharmaceuticals, medicine, or biotechnology.
• At least nine years of regulatory affairs experience encompassing drug development, approval, product launches, line extensions, license maintenance, or health authority roles.
• A minimum of five years within multinational pharmaceutical settings with proven impact.
• Comprehensive understanding of local and global regulatory standards and best practices.
• Proven skill in managing major projects and resource allocation.
• Strong collaborative skills to work effectively with global teams.
• Demonstrated ability to lead and develop personnel.
• Business insight including financial and strategic understanding.

Why Join AstraZeneca?

AstraZeneca provides a supportive workplace that promotes scientific advancement and entrepreneurial spirit. It maintains an inclusive culture emphasizing diversity, collaboration, and continuous learning, aiming to pioneer future developments in healthcare.