💊 AstraZeneca Recruitment 2026 – International CMC Regulatory Affairs Manager I
AstraZeneca is hiring an International CMC Regulatory Affairs Manager I in India. This is a senior opportunity for experienced professionals with expertise in CMC Regulatory Affairs, regulatory submissions, pharmaceutical manufacturing, and drug development.
📌 Job Details
- Company: AstraZeneca
- Post: International CMC Regulatory Affairs Manager I
- Job ID: R-258782
- Location: India
- Experience: Minimum 8 years
- Qualification: University degree in Science, Pharmacy, Biology, Chemistry or related technical field
- Industry: Pharma / Healthcare / Clinical Research
- Last Date: 10 September 2026
🧪 Key Responsibilities
- Manage preparation and delivery of CMC documentation for regulatory submissions.
- Author and coordinate CMC contributions for marketing applications and post-approval activities.
- Deliver submission-ready CMC modules in compliance with AZ procedures.
- Manage international CMC regulatory submission projects and timelines.
- Monitor and communicate Health Authority approval status.
- Apply regional regulatory requirements and regulatory intelligence.
- Support regulatory strategy and optimize submission content.
- Participate in CMC regulatory meetings and communicate project updates.
- Apply GxP principles and risk management throughout the product lifecycle.
- Support change-management and business-process optimization activities.
- Maintain and develop expertise in regulatory requirements and agency guidance.
🎓 Candidate Profile
Candidates should have:
- A degree in Pharmacy, Biology, Chemistry, Biological Science or another relevant scientific/technical field.
- Minimum 8 years of relevant experience in the biopharmaceutical industry or related field.
- Experience with CMC Regulatory Affairs and medicinal-product submissions.
- Knowledge of pharmaceutical manufacturing and drug-development processes.
- Understanding of current CMC regulatory requirements.
- Knowledge of regulations governing manufacture of medicinal products.
- Strong stakeholder and project-management skills.
- Good IT and regulatory capabilities.
- Understanding of GxP, Lean and risk-management principles.
⭐ Suitable Candidates
This role is particularly relevant for experienced professionals working in:
CMC Regulatory Affairs | Regulatory Submissions | Pharmaceutical Manufacturing | Regulatory Strategy | Drug Development | Biologics | Synthetics | Post-Approval Regulatory Affairs
🔗 Apply Online
AstraZeneca Careers – International CMC Regulatory Affairs Manager I
Last Date to Apply: 10 September 2026
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