Regulatory Affairs Lead

Astrazeneca Pharma India Ltd.; Riyadh; On-site; SAR 360,000 - 520,000; Full time

Job summary

AstraZeneca seeks a Regulatory Affairs Lead in Saudi Arabia to drive regulatory strategies and manage submissions across the product lifecycle, ensuring global and local compliance. The role partners with business units and authorities to enable timely patient access to innovative medicines.

You will lead a small team, provide expert regulatory input to product teams, and represent the company in official engagements with authorities while upholding governance and compliance standards.

Qualifications

• Minimum 9 years experience in regulatory affairs
• At least 5 years in a multinational environment
• Strong knowledge of local and international regulatory standards
• Proven ability to lead pivotal regulatory projects
• Excellent collaboration and people management skills

Responsibilities

• Drive regulatory strategy and submissions across product lifecycle
• Partner with business units and stakeholders to align regulatory plans
• Lead and develop a small team of regulatory professionals
• Engage with authorities and industry forums to shape guidelines
• Ensure governance, compliance and timely reporting and communications

Skills

Regulatory strategy

Submission management

Cross-functional leadership

Regulatory risk management

Industry/Health Authority liaison

Education

Bachelor's degree in Pharmaceuticals/Medicine/Biotechnology

Job description

ROLE SUMMARY

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements The role provides expert advice on processes and documentation proactively manages regulatory risks and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines The role reports to the Regulatory Affairs amp Pricing Director and supports the RA agenda through the established RA governance

What you ll do

Regulatory Strategy amp Submissions

• Lead submission management and cross-functional teams for complex global regulatory applications
• ensuring compliance with AstraZeneca s submission-ready standards
• Provide regulatory expertise and strategic input to product and project teams
• anticipating Health Authority requirements and guiding submissions-related activities
• Identify potential regulatory risks to global and regional operational plans
• proposing mitigation strategies
• Implement and oversee strategies that improve the quality efficiency and timeliness of submissions
• Manage processes related to product licenses registrations and post-marketing requirements including labeling safety reporting inspections and audits
• Act as the primary regulatory contact with key authorities e g SFDA GHC and ensure timely updates to global systems on regulatory guidelines decrees and communications

Business Partnering amp Country RA Agenda

• Partner with Business Units and relevant internal stakeholders to support the country regulatory agenda
• under the leadership of the Regulatory Affairs amp Pricing Director
• Conduct regular meetings with local agents regulatory teams to align on outstanding activities and ensure smooth execution
• Foster alignment across therapy area RA managers local agents and global stakeholders on regulatory priorities
• Represent AstraZeneca s regulatory interests in official engagements with authorities and industry forums

Leadership amp People Development

• Manage and develop a small team of regulatory professionals
• 1 2 direct reports setting clear objectives coaching and providing growth opportunities
• Promote a culture of collaboration creativity and courageous leadership across teams
• Lead or participate in critical projects ensuring regulatory business needs are integrated into AZ s systems processes and standards

External Engagement amp Business Awareness

• Build and maintain strong relationships with Regulatory Health Authorities industry representatives and key external partners
• Monitor regulatory policy and industry dynamics proactively advising internal stakeholders on potential impacts
• Support business development activities including proposals reports costing and budgets ensuring alignment with corporate strategy

Governance amp Compliance

• Ensure all regulatory activities adhere to AstraZeneca s Code of Ethics corporate policies and local legislation
• Timely reporting of adverse events compliance risks conflicts of interest and health environment-related incidents
• Provide regulatory input for audits inspections recalls and related communications to minimize compliance risks

Only applications in KSA will be considered

Saudi National

Higher education in pharmaceuticals, medicine, or biotechnology.

Minimum 9 years experience in regulatory affairs (drug development, product approval/launch, line extension, license maintenance, or Health Authority experience), including at least 5 years in a multinational environment with proven contributions.

Strong knowledge of local and international regulatory standards, requirements, and industry practices.

Demonstrated ability to manage pivotal projects and resource requirements.

Excellent collaboration and teamworking skills across global functions.

Proven people management capabilities.

Strong business acumen, including financial and strategic awareness.