Job Opportunity: International CMC Regulatory Affairs Manager I & II

Job Summary

AstraZeneca is seeking experienced regulatory professionals to join our team in Bangalore, India, as International CMC Regulatory Affairs Managers (Levels I & II). This is a high-impact, full-time position focused on the Chemistry, Manufacturing, and Controls (CMC) aspects of global drug development. The successful candidates will lead regulatory strategies, manage end-to-end dossier preparation for global submissions, and ensure compliance across the product lifecycle. This hybrid role (3 days per week in the office) offers a unique opportunity to influence the delivery of life-changing therapies while working within a collaborative, cross-functional global environment.

Responsibilities

CMC Submission & Documentation

• Prepare, author, and manage high-quality CMC documentation (Module 3) for regulatory filings.
• Ensure all submission-ready documentation adheres to rigorous global quality standards.
• Provide expert support for MAA, IND, CTA, and post-approval variations, ensuring accuracy and regulatory alignment.

Regulatory Strategy & Lifecycle Management

• Lead the development and execution of CMC regulatory strategies throughout the entire product lifecycle.
• Manage post-approval activities, including variations and renewals, to ensure continuous market access.
• Utilize regulatory intelligence to optimize submission content and proactively address potential challenges.

Project & Stakeholder Management

• Coordinate effectively with cross-functional departments, including Quality Assurance, Manufacturing, and R&D.
• Take ownership of timelines to ensure the timely and successful delivery of all regulatory submissions.
• Provide clear and consistent updates to global stakeholders regarding project status and regulatory milestones.

Compliance & GxP

• Maintain strict compliance with ICH guidelines, GxP standards, and all relevant global regulatory requirements.
• Oversee comprehensive documentation of health authority communications and maintain accurate regulatory records.
• Support risk management initiatives and robust change control processes.

Requirements

Essential Qualifications

• Education: A degree in Pharmacy, Life Sciences, Chemistry, or Biology.
• Experience:
  • Manager I: Minimum of 8+ years of relevant experience in regulatory CMC.
  • Manager II: Minimum of 10+ years of relevant experience in regulatory CMC.
• Expertise: Demonstrated knowledge of CMC regulatory requirements, global submission processes (US, EU, and ROW), and the full drug development lifecycle.

Skills Required

• Advanced regulatory writing skills with a focus on dossier preparation.
• Strong project management and stakeholder coordination abilities.
• Excellent analytical, problem-solving, and critical thinking skills.
• Proficiency in regulatory software, IT systems, and submission management tools.

Desirable Qualifications

• Experience with eCTD submissions.
• Detailed understanding of manufacturing regulations.
• Exposure to Lean methodologies or process optimization.

Why Join AstraZeneca?

AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines. By joining our team, you will:

• Work on complex, global regulatory submissions that impact patients worldwide.
• Gain exposure to the full product lifecycle, from initial development to post-marketing.
• Collaborate with diverse, cross-functional global teams in a supportive environment.
• Enjoy a clear trajectory for career advancement within regulatory strategy.

Compensation

• Manager I: ₹18 – ₹28 LPA
• Manager II: ₹28 – ₹45 LPA
  (Note: Salary is competitive and based on current industry benchmarks for the Indian market.)

Location

• Bangalore, Karnataka, India (Hybrid Work Model: 3 days in-office).

How to Apply

If you are a dedicated regulatory professional looking to advance your career with a global leader, we invite you to apply through the official AstraZeneca careers portal:

• Apply for International CMC Regulatory Affairs Manager I
• Apply for International CMC Regulatory Affairs Manager II

AstraZeneca is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.