PHARMAFull-time
International CMC Regulatory Affairs Manager I
By Admin · Regulatory Affairs
BANGALORE (IN)HYBRIDPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Manage the timely preparation, authoring, and delivery of Chemistry, Manufacturing and Controls (CMC) contributions to regulatory submissions for medicinal products throughout marketing authorisation applications and post-approval activities.
Deliver submission-ready CMC modules to internal and external regulatory stakeholders in compliance with AstraZeneca systems, procedures, and quality requirements.
Ensure the quality and completeness of CMC submission documentation.
Maintain and communicate Health Authority approval status.
Develop and apply expertise in regional and international regulatory requirements to ensure CMC submission compliance.
Project-manage international CMC regulatory submissions and adapt delivery plans to changing requirements while maintaining timelines.
Contribute to and lead regulatory CMC components of business-related projects.
Support agreed regulatory strategies by applying regulatory intelligence and optimizing submission content.
Participate in regulatory execution and delivery meetings and provide relevant updates to CMC teams.
Share project learnings with colleagues and across relevant functions.
Contribute to business-process optimization activities aimed at reducing waste and improving efficiency.
Proactively record and communicate Health Authority interactions, responses, and commitments to continually develop regulatory expertise.
Apply GxP principles appropriately throughout the product lifecycle.
Take responsibility for assigned change-management activities.
Apply appropriate risk-management principles across assigned activities.
Research and interpret regulations and guidance issued by different regulatory agencies.
CMC Regulatory & Technical Expertise
Manage CMC documentation for designated synthetic and biologic product ranges.
Support international regulatory submissions across the product lifecycle.
Apply current CMC regulations and guidance within AstraZeneca.
Contribute to the development of new regulatory guidance, policies, and processes.
Maintain awareness of manufacturing, technical, project, and regulatory management requirements.
Support regulatory strategy and submission-content optimization through regulatory intelligence.
Stakeholder & Project Management
Maintain effective communication with stakeholders and project team members.
Communicate regulatory timelines, commitments, risks, and relevant updates clearly.
Coordinate activities required for submission delivery across international markets.
Adapt project-management approaches to changing situations while maintaining on-time delivery.
Contribute to cross-functional business projects and regulatory execution meetings.
Qualifications & Experience
University degree in a science or technical discipline such as Pharmacy, Biology, Chemistry, or Biological Science.
Minimum 8 years of relevant experience in the biopharmaceutical industry or other relevant experience.
Broad knowledge of manufacturing, project management, technical management, and regulatory management.
IT skills and stakeholder/project management capabilities.
Strong professional regulatory knowledge.
Desirable Expertise
Knowledge of the drug development process and regulatory submissions.
Understanding of current regulatory CMC requirements.
Direct or indirect CMC Regulatory Affairs experience involving medicinal-product submissions.
Understanding of regulations and guidance governing the manufacture of medicinal products.
Lean capabilities.
Work Arrangement
Full-time role based in Bangalore, India.
Hybrid working model.
AstraZeneca expects employees to work from the office on average at least three days per week while maintaining flexibility.
Career & Company Environment
AstraZeneca is a science-led, patient-focused biopharmaceutical company involved in the discovery, development, and commercialization of prescription medicines.
The role provides exposure to meaningful science and the full drug-development journey.
Regulatory professionals collaborate across locations, therapy areas, and external partners.
The organization emphasizes modern regulatory approaches, data and analytics, innovation, inclusion, and opportunities to develop skills and explore different roles.
REQUIRED VERIFIED SKILLS
Science or Technical Degree
Pharmacy
Biology
Chemistry
Biological Science
CMC Regulatory Affairs
Regulatory Submissions
CMC Documentation
Medicinal Products
Marketing Authorisation Applications
Post-Approval Activities
Regulatory Compliance
International Regulatory Requirements
Regulatory Intelligence
GxP
Risk Management
Change Management
Health Authority Interactions
Project Management
Stakeholder Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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