Regulatory Affairs Senior Manager, Regional CoE

Astrazeneca Pharma India Ltd.; Riyadh; On-site; SAR 350,000 - 550,000; Full time

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.

Skills

Regulatory leadership

Cross-functional collaboration

Stakeholder management

Communication

Autonomy

Regulatory judgment

Data management

Education

University degree in Pharmacy or related field

Tools

Veeva RIM

ERV

Regulatory submission systems

Job description

LCM Portfolio Leadership

Lead the regional Life Cycle Management portfolio ensuring alignment with business priorities agreed service levels and quality and compliance expectations

Demand and Resource Management

Manage intake prioritization work allocation capacity visibility and governance of activities transferred from Marketing Company teams

Operational Strategy and Regulatory Execution

Lead complex or high-impact activities related to dossier customization regulatory submissions national requirements post-approval pathways and CMC change management

Dossier Preparation

Ensure the preparation compilation and quality review of country-ready regulatory packages including Module 1 national forms cover letters declarations local administrative documentation translations and ERV activities where applicable

Submissions and Tracking

Execute or support regulatory submissions under the agreed operating model maintain submission evidence and ensure regulatory records remain complete and current

Health Authority Questions Management

Coordinate the receipt assignment consolidation and timely submission of responses to health authority questions ensuring appropriate involvement of Marketing Companies iRAMs iRADs and iCMC

Implementation and Closure

Oversee approval follow-up activities implementation of variations and commitments regulatory system updates and compliant closure of activities

Labeling Adaptation and Implementation

Where applicable lead regional capabilities for labeling adaptation and implementation ensuring appropriate use of tools templates and quality controls

Standardization and Continuous Improvement

Design and enhance processes templates national requirements guides artwork coordination workflows and automation opportunities to improve efficiency and right-first-time quality

Risk Management

Identify and manage regulatory CMC supply quality resource and timeline risks recommending and implementing appropriate mitigation measures

Issue Resolution

Lead the investigation and resolution of portal rejections administrative non-compliance execution failures or schedule deviations including root cause analysis and implementation of corrective actions

Governance and Performance Management

Manage performance indicators related to workload volume timeliness right-first-time quality data quality response times to health authority questions implementation and activity closure

Leadership and Capability Building

Provide matrix leadership coaching knowledge transfer development planning and deployment of specialized expertise within the team

Stakeholder Management

Build strong relationships with Regulatory leaders in Marketing Companies iRAMs iRADs iCMC and partners across Manufacturing Supply Quality Labelling Patient Safety and Regulatory Operations

Compliance

Ensure activities are executed in accordance with Good Regulatory Practice GRP AstraZeneca policies GxP requirements the Code of Ethics and applicable functional procedures

Essential Capabilities

• Education: University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory Experience: Minimum 7 years of extensive experience in regulatory affairs for biopharmaceutical products, including significant responsibility for Life Cycle Management of assigned products, national submissions, labeling, and regulatory CMC activities.
• Multinational Experience: Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.
• Technical Knowledge: Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.
• Portfolio Leadership: Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.
• Stakeholder Management: Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners.
• Communication: Excellent written and verbal communication skills in English, with the ability to present technical information, risks, alternatives, and recommendations to senior stakeholders.
• Autonomy and Professional Judgment: Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy.
• Scientific and Regulatory Judgment: Ability to evaluate technical and regulatory information, identify gaps, and provide practical, evidence-based recommendations.
• Systems and Data Management: Experience using regulatory information systems, records management tools, submission tracking systems, and regulatory data maintenance processes.

Desirable Capabilities

• Experience leading Centres of Excellence, regional hubs, shared services models, or transformation programs.
• Experience with Veeva RIM, ERV, or other regulatory planning, analytics, and management platforms.
• Experience implementing automation, digital workflows, dashboards, or continuous improvement solutions.
• Experience working with small molecules, biologics, or biotechnology-derived products.
• Experience partnering with Manufacturing, Supply, Quality, Labelling, and other functions involved in post-approval change implementation.