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Icmc Regulatory Affairs Manager I

8+ years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time 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

Here’s the structured job description:


iCMC Regulatory Affairs Manager I

Job ID: R-214617
Date Posted: 02/11/2025
Career Level: D1

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company committed to discovering, developing, and commercializing life-changing medicines. We focus on addressing unmet medical needs and improving patient outcomes worldwide.

Role Introduction

As an iCMC Regulatory Affairs Manager I, you will oversee the preparation of Chemistry, Manufacturing, and Control (CMC) documentation, ensuring compliance with AstraZeneca’s and global regulatory standards. You will manage CMC regulatory submissions throughout the product lifecycle and contribute to business-related projects. This role requires effective collaboration, project management, and a strong understanding of international CMC regulations.

Key Responsibilities:

  • Prepare and manage CMC documentation for regulatory submissions across the product lifecycle.
  • Ensure submission-ready CMC modules meet AstraZeneca’s quality and regulatory requirements.
  • Maintain documentation and communicate Health Authority approval status.
  • Develop expertise in regional regulatory requirements to ensure compliance.
  • Adapt to changing project needs to meet timelines effectively.
  • Share learnings and insights from regulatory projects with internal teams.
  • Participate in regulatory execution meetings and provide updates.
  • Contribute to business process optimizations to enhance efficiency.
  • Maintain records of Health Authority interactions, responses, and commitments.
  • Apply GxP principles based on the product lifecycle stage.
  • Support organizational change initiatives as assigned.
  • Conduct research to understand regulations from various agencies.

Required Qualifications & Experience:

  • Education: University degree in pharmacy, biology, chemistry, or a related technical field.
  • Experience: Minimum 8 years in the biopharmaceutical industry or a relevant role.
  • Skills:
    • Strong regulatory knowledge and experience with regulatory CMC submissions.
    • Understanding of manufacturing, project, technical, and regulatory management.
    • Strong IT skills and project management capabilities.

Preferred Qualifications:

  • Knowledge of the drug development process and regulatory submissions.
  • Experience with CMC submissions for synthetic and biologic/biotechnology-derived products.
  • Understanding of regulations governing monoclonal antibodies and complex biologics.
  • Lean capabilities and process optimization experience.

Work Environment & Culture

AstraZeneca fosters a collaborative and innovative environment. Employees are expected to work a minimum of three days per week from the office while balancing flexibility based on individual needs. Our inclusive team values diverse experiences and perspectives, driving impactful drug development strategies.

Join Us!

At AstraZeneca, we are committed to transforming scientific advancements into life-changing medicines. If you are ready to contribute to groundbreaking healthcare solutions, apply today!

Equal Opportunity Employer

AstraZeneca is committed to diversity, equity, and inclusion, ensuring a fair hiring process for all candidates regardless of background.

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