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International Associate Regulatory Affairs Director Ii

12+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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