💼 AstraZeneca Hiring for 3 Regulatory Affairs Roles | Mumbai | 0–6 Years | M.Pharm, B.Pharm, M.Sc
📍 Location: Mumbai, India
🎓 Eligibility: M.Pharm / B.Pharm / M.Sc
🧪 Experience: 0–6 Years
📝 Job Type: Regulatory Affairs | Executive Assistant RA & Assistant Manager RA
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
📄 Job Overview
AstraZeneca, a global biopharmaceutical leader, is hiring for three Regulatory Affairs roles in Mumbai. These roles offer opportunities to work on drug approvals, regulatory strategy, lifecycle management, PSUR submissions, and compliance functions.
If you're looking to grow in Regulatory Affairs, drug approval pathways, and global regulatory compliance—this is the right time to apply.
📌 Roles Available
- 1️⃣ Executive Assistant – Regulatory Affairs (R-240764)
- 2️⃣ Executive Assistant – Regulatory Affairs (R-240766)
- 3️⃣ Assistant Manager – Regulatory Affairs (R-240790)
1️⃣ Executive Assistant – Regulatory Affairs (Mumbai)
🔬 Key Responsibilities
- ✔ Submit responses to Health Authority queries.
- ✔ Maintain regulatory documentation and submission trackers.
- ✔ Support India-specific artwork development & compliance.
- ✔ Prepare & submit NDAs, GCT applications, site registrations & import licenses.
- ✔ Prepare and submit India-specific PSURs.
- ✔ Support lifecycle management activities including renewals & variations.
- ✔ Support audits, CAPA, deviations & regulatory inspections.
- ✔ Maintain sample testing documentation for NIBL / CDTL.
🎓 Qualifications
- 🎓 Bachelor’s or Master’s degree
- 🧪 Experience in QA/QC or regulatory areas preferred but not mandatory
- No minimum experience required
2️⃣ Executive Assistant – Regulatory Affairs (2nd Listing)
This role carries the same responsibilities & skillsets as Role #1, under a separate requisition ID.
3️⃣ Assistant Manager – Regulatory Affairs (Mumbai)
🔬 Key Responsibilities
- ✔ Develop regulatory strategies for NCE & accelerated approvals.
- ✔ Submit NDAs, site registrations & import licenses.
- ✔ Manage ADC sample testing & registration sample lifecycle.
- ✔ Submit India-specific PSURs.
- ✔ Track product lifecycle changes & license renewals.
- ✔ Work with Health Authorities for approvals.
- ✔ Conduct regulatory intelligence & pipeline evaluation.
- ✔ Support RA activities for global clinical trials & post-marketing studies.
🎓 Qualifications
- 🎓 M.Pharm / B.Pharm / M.Sc
- 🧪 3–6 years of experience in Regulatory Affairs
- 📑 Strong understanding of Indian drug regulations & dossier preparation
🎁 Why Join AstraZeneca?
- 🌍 Work with a global biopharma leader.
- 📈 Contribute to high-impact drug approvals.
- 🧪 Exposure to global regulatory frameworks.
- 💼 Collaborative & development-focused environment.
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🟢 Verified Job via Medical Jobs India – hitechplus.in
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