Job Title: Executive – Regulatory Affairs
Location: Mumbai, India
About AstraZeneca:
AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines. We are focused on addressing unmet medical needs in core therapeutic areas including oncology, cardiovascular, renal & metabolism, and respiratory & immunology. Our culture fosters innovation, integrity, and collaboration, providing an environment where employees can grow and make a real difference to global healthcare.
Job Summary:
We are seeking a highly motivated and detail-oriented Executive – Regulatory Affairs to join our team in Mumbai. In this role, you will be responsible for supporting regulatory submissions, ensuring compliance with regulations, managing PSURs (Periodic Safety Update Reports), and contributing to the lifecycle management of our products. This is an excellent opportunity for a skilled regulatory professional to advance their career within a globally respected organization and contribute to innovative healthcare solutions.
Responsibilities:
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Regulatory Documentation & Compliance:
- Collate and prepare responses to queries from Health Authorities.
- Maintain accurate submission trackers and comprehensive documentation records.
- Ensure adherence to AstraZeneca’s code of conduct, global regulatory policies, and local legislation.
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Regulatory Submissions & Dossier Preparation:
- Support the compilation and submission of New Drug Applications (NDAs), applications for additional indications, and Global Clinical Trial (GCT) applications.
- Assist with site registrations and import license applications.
- Manage queries from regulatory authorities until approval or closure of submissions.
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Artwork & Lifecycle Management:
- Support the development of India-specific artwork for product packaging and labeling, ensuring alignment with regulatory requirements.
- Manage product license changes and lifecycle updates to maintain compliance.
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PSUR & Safety Reporting:
- Prepare India-specific PSURs based on global Periodic Benefit-Risk Evaluation Reports (PBRERs).
- Submit PSURs within required timelines and address any queries from Health Authorities.
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Regulatory Intelligence:
- Track and circulate new guidelines, circulars, and other regulatory updates to relevant stakeholders, ensuring proactive action and compliance.
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Audit Support:
- Maintain audit-ready documentation and actively participate in internal and external audits.
- Assist in the implementation of corrective and preventive actions (CAPA) related to audit findings and deviations.
Requirements:
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Essential:
- Bachelor’s degree in a relevant life sciences or regulatory field (e.g., Pharmacy, Biology, Chemistry).
- Proven experience in quality assurance or regulatory affairs within the pharmaceutical industry.
- Strong understanding of regulatory requirements and guidelines in India.
- Excellent attention to detail, organizational, and time-management skills.
- Ability to work independently and collaboratively within a team environment.
- Strong communication and interpersonal skills.
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Desirable:
- Postgraduate degree in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline.
- Experience with electronic submission platforms and regulatory databases.
Benefits:
- Be a part of a globally recognized, science-led organization committed to innovation.
- Contribute to the development and commercialization of medicines that make a positive impact on patients worldwide.
- Work within an inclusive and diverse culture that values learning, collaboration, and employee growth.
- Gain exposure to high-impact regulatory projects and opportunities for professional development.
- Competitive salary and benefits package.
How to Apply:
If you are a motivated and experienced regulatory professional looking for a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and cover letter through our online application portal. We look forward to hearing from you!