Join AstraZeneca’s Regulatory Affairs Team in Mumbai!
Summary: AstraZeneca, a global biopharmaceutical leader, is seeking talented and motivated individuals to join our Regulatory Affairs team in Mumbai. We have multiple openings, including Executive Assistant and Assistant Manager roles, offering the opportunity to contribute to drug approvals, regulatory strategy, and compliance within a dynamic and innovative environment. If you’re passionate about pharmaceutical compliance and drug approval processes, we encourage you to apply.
Available Positions:
- Executive Assistant – Regulatory Affairs (Two Positions Available)
- Assistant Manager – Regulatory Affairs
1. Executive Assistant – Regulatory Affairs (Requisitions: R-240766 & R-240764)
About the Role:
As an Executive Assistant in Regulatory Affairs, you will play a crucial role in supporting the regulatory activities for AstraZeneca’s products in India. You will be responsible for a variety of tasks, including documentation management, submission preparation, and communication with health authorities. This position offers an excellent opportunity to gain experience in the pharmaceutical regulatory landscape and contribute to the successful registration and maintenance of our products.
Key Responsibilities:
- Compile, communicate, and submit responses to Health Authority queries, ensuring timely and accurate information delivery.
- Maintain meticulous regulatory documentation and submission trackers to ensure compliance and audit readiness.
- Support India-specific artwork development, ensuring compliance with local regulations and guidelines.
- Assist in the preparation and submission of New Drug Applications (NDAs), Global Clinical Trial (GCT) applications, site registrations, and import licenses.
- Prepare and submit India-specific Periodic Safety Update Reports (PSURs) based on global Periodic Benefit-Risk Evaluation Reports (PBRERs).
- Coordinate lifecycle management activities, including timely renewals and amendments to existing product licenses.
- Support audits, address deviations, and implement Corrective and Preventive Actions (CAPAs) to maintain regulatory compliance.
- Stay updated on evolving regulatory guidelines and requirements through proactive Regulatory Intelligence gathering.
- Manage sample testing documentation for NIBL/CDTL, ensuring accurate record-keeping and compliance.
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Pharmacy, Science).
- Experience in Quality Assurance (QA) or Quality Control (QC) within a pharmaceutical manufacturing environment is highly desirable.
- Post-graduate qualification is a plus.
- Experience is preferred, but not mandatory. This is a great opportunity for individuals looking to enter the Regulatory Affairs field.
2. Assistant Manager – Regulatory Affairs (Requisition: R-240790)
About the Role:
As an Assistant Manager in Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies for new chemical entities (NCEs) and accelerated approvals in the Indian market. You will ensure compliance with Indian regulations and global regulatory policies, working closely with health authorities and internal stakeholders. This role requires a strong understanding of drug development processes and regulatory requirements.
Key Responsibilities:
- Develop and implement effective regulatory strategies for NCEs and accelerated approval pathways, maximizing speed to market.
- Ensure comprehensive compliance with Indian regulations and adherence to global regulatory policies and standards.
- Prepare and submit high-quality regulatory dossiers, including NDAs, site registration documents, and import license applications.
- Manage Antibody-Drug Conjugate (ADC) sample testing and registration sample lifecycle, ensuring timely and compliant processes.
- Prepare and submit India-specific PSURs, contributing to the ongoing safety monitoring of our products.
- Track product license changes and ensure timely renewals, preventing any disruption to product availability.
- Liaise with Health Authorities for approvals and regulatory updates, fostering positive relationships and ensuring clear communication.
- Conduct competitive intelligence and pipeline analysis, identifying potential regulatory challenges and opportunities.
- Support RA activities for global clinical trials, Phase IV, and Post-Marketing Surveillance (PMS) studies, ensuring regulatory compliance throughout the drug development process.
Qualifications:
- M.Pharm / B.Pharm / M.Sc degree required.
- 3–6 years of experience in India Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of dossier compilation and Indian drug regulations is essential.
- Excellent communication, interpersonal, and problem-solving skills.
Why Join AstraZeneca Mumbai?
- Global Impact: Work with a global biopharmaceutical leader impacting the lives of millions of patients worldwide.
- Real-World Contribution: Directly contribute to real-world drug development and approvals, seeing your work make a tangible difference.
- Dynamic Culture: Thrive in a dynamic and collaborative culture focused on innovation, continuous learning, and professional development.
- Global Exposure: Gain exposure to global regulatory frameworks, audits, and compliance systems, expanding your knowledge and skills.
How to Apply
Interested candidates are encouraged to apply through the following links:
- Executive Assistant – Regulatory Affairs (R-240764): [Application Link]
- Executive Assistant – Regulatory Affairs (R-240766): [Application Link]
- Assistant Manager – Regulatory Affairs (R-240790): [Application Link]
We look forward to receiving your application!