Job Title:
International Associate Regulatory Affairs Director II
Job ID:
R-224237
Company:
AstraZeneca
Location:
Bangalore, India
Work Type:
Full-time (Hybrid – minimum 3 days/week in office)
Posting Date:
April 11, 2025
Application Deadline:
April 25, 2025 (9 days left to apply)
Job Level:
Global Career Level: E
Key Responsibilities:
Lead the International Regulatory Team (IRT) for Established Biopharma Brands.
Serve as both International Regulatory Lead & iRAM Lead for assigned products.
Drive planning and submission of regulatory strategies and documents, including MAAs, CLEs, and LCM applications.
Collaborate cross-functionally across International & Global Regulatory Affairs.
Monitor variations with iCMC to align regulatory plans with business needs.
Analyze regulatory procedures and designations; manage risk and compliance.
Support HAQ responses and strategic issue resolution.
Share best practices within the RAM community and mentor peers.
Essential Qualifications:
University degree in Science or related field.
12+ years of experience in biopharma regulatory affairs, specifically with International markets.
Deep understanding of international drug development and regulatory frameworks.
Demonstrated success in lifecycle management, license maintenance, safety, and labeling.
Strategic, collaborative leader with excellent communication and problem-solving skills.
Preferred Qualifications:
Strong English communication skills.
Cross-cultural competence and global team leadership experience.
Familiarity with tools like MS Project and document management systems.
Proactive, analytical mindset focused on continuous improvement.
Why Join AstraZeneca?
Work on impactful projects in a global setting.
Contribute to life-changing medicines and innovative science.
Thrive in a collaborative, fast-paced, and supportive environment.
Be part of a company that values diversity, equity, and inclusion
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