Job opportunity as Regulatory Affairs Associate I at AstraZeneca- Apply before 25th Aug. 2025

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company dedicated to transforming the lives of patients through innovation and excellence in drug development and commercialization. We focus on some of the world’s most serious diseases and are driven by a strong purpose: to push the boundaries of science to deliver life-changing medicines.

We are now hiring passionate professionals to join our Regulatory Affairs team in Bangalore, India.

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Position: Regulatory Affairs Associate I

Department: Global Regulatory Execution Team (GRET)
Location: Bangalore
Experience Required: 3 to 5 years
Qualification: Graduate in Science or Pharmacy
Industry: Pharmaceuticals / Biotech / Clinical Research
Application Deadline: 25th August 2025

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Key Responsibilities

• Upload, manage, and track regulatory documents in accordance with internal procedures and global health authority requirements.

• Prepare and execute simple regulatory submissions and dispatches.

• Act as liaison with global Health Authorities (FDA, EMA, etc.) for regulatory tasks and documentation including CPPs, user fees, and priority review vouchers.

• Coordinate EU-specific submissions: EudraCT numbers, EMA linguistic reviews, EudraLink support, and CPP/legal document orders.

• Manage regulatory logistics including samples, Letters of Authorization, Power of Attorney, and document translations.

• Support global initiatives including CTIS submissions, eTMF uploads, and quarterly QC checks.

• Serve as Veeva Regulatory Vault (ERV) and Clinical Vault (VCV) support for Regulatory Affairs Managers (RAMs).

• Support audits, tenders, and cross-functional process improvements.

• Provide operational support and knowledge sharing across teams.

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Candidate Profile

• Graduate in Science or Pharmacy with 3–5 years of relevant industry experience.

• Strong written and verbal communication skills in English.

• Proficient in document management systems, particularly Veeva ERV and VCV.

• Understanding of global regulatory environments (especially EU and US).

• Ability to work flexibly with global stakeholders across time zones.

• Detail-oriented, organized, and adept at multi-tasking in a deadline-driven environment.

• Prior experience in CTIS submissions and regulatory operations is a plus.

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Why AstraZeneca?

• Work alongside world-class professionals in a high-impact, innovation-driven environment.

• Be part of a global team that shapes the future of healthcare.

• Continuous learning, development, and career growth opportunities.

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Apply now and become part of our mission to deliver life-changing medicines to patients worldwide.