Senior Regulatory Affairs Leader — Life Cycle Management

Astrazeneca Pharma India Ltd.

Riyadh

On-site

SAR 350,000 - 550,000

Full time

5 days ago

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Job summary

Astrazeneca Pharma India Ltd. is seeking an experienced Regulatory Portfolio Leader in Saudi Arabia to steer regional lifecycle activities and ensure alignment with business priorities and regulatory expectations.

You will lead cross-functional teams across Marketing, Manufacturing, Quality, and Regulatory Operations to deliver timely, compliant dossiers and submissions. The role requires strong leadership, extensive regulatory expertise, and the ability to drive continuous improvement across

Qualifications

University degree or equivalent in a science or related field.
7+ years regulatory affairs experience in biopharma, with Life Cycle Management
Experience across multiple markets and national regulatory requirements
Strong knowledge of post-approval regulatory frameworks and CMC
Ability to lead cross-functional teams and drive regulatory strategy

Responsibilities

Lead regional Life Cycle Management portfolio aligning with priorities and regulations.
Manage intake, prioritization, governance for activities from Marketing Companies.
Oversee dossier preparation, regulatory submissions, and record-keeping.
Coordinate responses to health authority questions with relevant stakeholders.
Drive governance, risk management, and continuous improvement initiatives.