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International Cmc Ra Director

2+ years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD 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 CMC RA Director
Job ID: R-215091
Date Posted: 12/12/2024
Career Level: F

Introduction to the Role:
As an International CMC RA Director, you will provide strategic, operational, and tactical expertise across the entire lifecycle of complex products, from development through to global launch and post-approval management. This role offers a unique opportunity to shape international CMC strategy, identify risks and mitigations, and ensure the needs of international markets, businesses, and patients are met.

Key Responsibilities:

  • Provide expert guidance across business functions, leading key business improvement initiatives in the CMC RA domain.
  • Direct and oversee CMC submissions for product lifecycles, from development to post-launch.
  • Manage high-level risks and make complex judgments, developing innovative solutions and proactively managing risks and mitigations.
  • Develop and maintain CMC RA expertise to support regulatory affairs submissions, ensuring compliance and readiness for international markets.

Essential Skills & Experience:

  • Degree or PhD (or equivalent professional qualification) in a science or technical field such as pharmacy, biology, chemistry, or biological science.
  • Extensive knowledge of manufacturing, project management, and regulatory affairs, with experience in regulatory project management.
  • Strong understanding of global regulatory affairs, particularly in the context of biotechnology products and monoclonal antibodies.
  • Direct experience with CMC submissions for synthetic, biologic, and biotechnology-derived products.
  • Stakeholder and project management expertise, with experience in regulatory health authority interactions, inspections, and policy advocacy.
  • Post-graduate qualifications and an understanding of business, financial, and supply chain concepts.

Work Culture:
At AstraZeneca, we believe that bringing together diverse teams fosters bold thinking and drives life-changing innovations. Our approach to in-person working—requiring a minimum of three days per week in the office—supports collaboration, pace, and new perspectives while respecting individual flexibility.

Our Mission:
In AstraZeneca's Biopharmaceuticals R&D division, we turn drug development strategies into reality, working across all stages to transform life-changing science into effective medicines. We are a diverse, open-minded team that embraces differences, enabling us to explore new ideas and approaches. We offer opportunities for fast career growth and development, supporting our ambition to make AstraZeneca the place to build a career in Regulatory Affairs.

Ready to make a difference?
Apply now and join us in shaping the future of regulatory affairs at AstraZeneca!

Diversity & Inclusion:
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team that reflects all backgrounds and harnesses a wide range of perspectives. We welcome applications from all qualified candidates, regardless of their characteristics, and comply with all applicable non-discrimination laws and regulations on work authorization and employment eligibility verification.