AstraZeneca Hiring Regulatory Affairs Professionals | 3 High-Paying RA Roles in Mumbai | Apply Now

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AstraZeneca Hiring for 3 Regulatory Affairs Roles | Mumbai | 0–6 Years | M.Pharm, B.Pharm, M.Sc

AstraZeneca

Mumbai

0–6 Years

Regulatory Affairs

M.Pharm / B.Pharm / M.Sc

📄 Job Overview

AstraZeneca is hiring for 3 Regulatory Affairs roles involving drug approvals, lifecycle management, PSUR submissions, regulatory strategy & compliance documentation.

📌 Roles Available

• Executive Assistant – Regulatory Affairs (R-240764)
• Executive Assistant – Regulatory Affairs (R-240766)
• Assistant Manager – Regulatory Affairs (R-240790)

1️⃣ Executive Assistant – Regulatory Affairs (R-240764)

🔬 Key Responsibilities:

• Submit responses to Health Authority queries
• Maintain regulatory documentation & submission trackers
• Support artwork development for India market
• Prepare NDAs, GCT applications & site registrations
• SUGAM portal submissions for import licenses
• Prepare and submit PSURs
• Lifecycle management: renewals, variations
• Support audits, CAPA & inspection readiness
• Prepare sample testing documentation (NIBL / CDTL)

🎓 Qualifications:

• B.Pharm / M.Pharm / M.Sc
• Experience in QA/QC/RA preferred, fresher eligible

2️⃣ Executive Assistant – Regulatory Affairs (R-240766)

🔬 Key Responsibilities:

• Submit responses to HA queries
• Maintain RA trackers & compliance docs
• Prepare NDAs & GCT submissions
• Artwork packaging compliance
• Submit PSURs
• Lifecycle variations & renewals
• Assist in audits & inspection readiness

🎓 Qualifications:

• B.Pharm / M.Pharm / M.Sc
• 0–2 years experience, freshers allowed

3️⃣ Assistant Manager – Regulatory Affairs (R-240790)

🔬 Key Responsibilities:

• Develop regulatory strategies for new products / NCEs
• Submit NDAs, import licenses & GCT filings
• Prepare India-specific PSURs
• Conduct regulatory intelligence
• Coordinate with Health Authorities
• Manage lifecycle changes & renewals
• Support global RA & clinical trial submissions
• Review manufacturing changes for RA impact

🎓 Qualifications:

• M.Pharm / B.Pharm / M.Sc
• 3–6 years experience in RA

🔎 More Verified Medical Jobs

📌 Note Before You Apply:
Please read the job description carefully before applying.
Make sure your qualifications match the requirements.

👇 Select Role to Apply 👇

-- Select Role -- Executive Assistant RA – R-240764 Executive Assistant RA – R-240766 Assistant Manager RA – R-240790

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