Regulatory Affairs Lead

Astrazeneca Pharma India Ltd.; Riyadh; Vor Ort; SAR 480.000 - 600.000; Vollzeit

Zusammenfassung

AstraZeneca is seeking a Regulatory Affairs Lead in Saudi Arabia to drive regulatory strategies and manage submissions across the product lifecycle. You will provide expert advice, proactively manage regulatory risks, and partner with authorities and internal stakeholders to enable timely patient access to innovative medicines.

You will lead a small team, collaborate with global and local functions, and ensure regulatory compliance across licensing, registrations, and post-marketing

Qualifikationen

• Saudi National only applications
• Higher education in pharmaceuticals, medicine, or biotechnology
• Minimum 9 years in regulatory affairs with multinational exp
• Strong knowledge of local and international regulatory standards
• Proven ability to manage pivotal regulatory projects and resources
• Excellent collaboration across global functions
• Proven people management capabilities
• Strong business acumen with financial and strategic awareness

Aufgaben

• Lead regulatory strategy and submissions for complex global applications.
• Provide regulatory expertise to product and project teams and anticipate Health Authority requirements.
• Identify regulatory risks and propose mitigation strategies.
• Manage licenses, registrations, post-marketing requirements, labeling, safety reporting, inspections and audits.
• Act as primary regulatory contact with authorities (e.g., SFDA, GHC).
• Partner with BU and internal stakeholders to support country regulatory agenda.
• Foster alignment across RA managers, local agents and global stakeholders on regulatory priorities.
• Represent AstraZeneca regulatory interests in official engagements with authorities and industry forums.
• Lead or participate in projects to integrate regulatory needs into AZ systems, processes and standards.

Kenntnisse

Regulatory leadership

Cross-functional collaboration

Stakeholder management

Project governance

Ausbildung

Pharma/Med/Bio degree

Jobbeschreibung

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 SubmissionsLead 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 AgendaPartner 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 DevelopmentManage 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 AwarenessBuild 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 ComplianceEnsure 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

QUALIFICATIONS

• 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.