Assistant Manager – Regulatory Affairs Job At AstraZeneca India
AstraZeneca India is hiring an Assistant Manager – Regulatory Affairs to lead regulatory strategy and compliance for pharmaceutical products. This Regulatory Affairs Job helps you manage new drug applications, site registrations, and PSUR submissions, and ensure timely approvals to drive business objectives while maintaining high regulatory standards. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
- Job Title: Assistant Manager – Regulatory Affairs
- Location: Mumbai, India
About the Company
AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for serious diseases. With over 45 years in India, AstraZeneca combines innovation, collaboration, and integrity to deliver life-changing medicines and sustainable healthcare solutions.
Key Responsibilities
- Develop and implement regulatory plans for assigned products to achieve rapid approvals and facilitate launches.
- Manage India-specific artwork and support dossier preparation for New Drug Applications, site registrations, and import licenses.
- Handle registration samples, ADC testing, and lifecycle management activities.
- Prepare and submit PSURs, respond to Health Authority queries, and maintain regulatory compliance.
- Monitor product licenses, manage changes, and maintain documentation records.
- Support submissions and review of global clinical trials, Phase IV, and PMS studies, including SEC preparation.
- Conduct competitive intelligence and regulatory analysis to guide strategy.
- Ensure adherence to AstraZeneca’s ethics, regulatory standards, and global codes of conduct.
Educational Qualification
- M. Pharm / B. Pharm
- 3–6 years of experience in India Regulatory Affairs.
- Knowledge of dossier compilation and Indian regulations related to new drugs and clinical trials.
Skills Required
- Expertise in regulatory submissions, lifecycle management, and compliance.
- Strong organizational, analytical, and communication skills.
- Ability to manage multiple projects, coordinate cross-functional teams, and meet strict timelines.
- Knowledge of PSUR preparation, SEC reporting, and regulatory documentation processes.
Why This Job Role?
This Regulatory Affairs Job role offers the chance to lead regulatory affairs for a global biopharmaceutical company, influence product approvals, and contribute to the delivery of life-changing medicines. Work in a collaborative, inclusive environment that values innovation, professional growth, and impact on patient health. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
