AstraZeneca Hiring International CMC Regulatory Affairs Manager

AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients delivering 20 new medicines to patients by 2030. This role is critical in contributing to AZ’s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the whole Enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business.

Post : International CMC Regulatory Affairs Manager I

Job Description
Introduction to role
The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. They project manage international CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.

Accountabilities
• Manage the timely preparation (include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout marketing authorisation applications and all post approval activities
• Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
• Documenting maintenance and communication of Health Authority approval status.
• Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
• Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
• Ensure the learning from own projects are shared with other colleagues/within the functions.

• Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content
• Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.
• Contribute to business process optimisation activities to reduce waste and ensure efficiency.
• Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.
• Apply GxP principles according to the stage of product lifecycle
• Responsibility for change management as assigned.
• Understands application of appropriate risk management across own activities.
• Demonstrate research skills in understanding regulations, and guidance from different regulatory agencies

Candidate Profile
• University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
• Minimum 8 years of Relevant experience from biopharmaceutical industry, or other relevant experience
• Breadth of knowledge of manufacturing, project, technical and regulatory management.
• IT Skills
• Stakeholder & Project management
• Professional capabilities: Regulatory knowledge
• Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements
• Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products
• Understanding of regulations and guidance governing the manufacture of medicinal products
• Lean capabilities

Additional Information
Experience : Minimum 8 years
Qualification : University degree in a science or pharmacy, biology, chemistry or biological science
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-258782
End Date : 10-Sept-2026