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Regulatory Affairs Director Cvrm

3+ 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

 


Regulatory Affairs Director – CVRM

Job ID: R-211084
Date Posted: 02/12/2025
Career Level: F

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company focused on developing innovative medicines that positively impact patients' lives. Within the Cardiovascular, Renal, and Metabolism (CVRM) Regulatory Affairs team, we leverage cutting-edge regulatory approaches to accelerate the development and commercialization of life-changing treatments.

Role Overview

As a Regulatory Affairs Director – CVRM, you will play a critical role in developing and implementing global regulatory strategies. You will provide strategic and operational leadership, ensuring regulatory excellence across early and late-stage development pipelines. This position offers the opportunity to engage with Health Authorities, influence regulatory decisions, and drive successful product approvals.

Key Responsibilities:

  • Define and implement global regulatory strategies for CVRM products.
  • Lead interactions with Health Authorities to shape and accelerate drug development.
  • Influence product development by integrating regulatory insights at all stages.
  • Ensure compliance with evolving regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams to drive strategic decision-making.
  • Evaluate and mitigate regulatory risks within development programs.
  • Foster a culture of regulatory innovation and continuous learning within the team.

Required Qualifications & Experience:

  • Education: Bachelor’s degree in a science-related field.
  • Experience:
    • Minimum 3+ years of experience in regulatory affairs within a pharmaceutical organization.
    • Proven track record of regulatory drug development, product approvals, and launches.
    • Experience in early and late-stage development within one or more therapeutic areas.
    • Demonstrated expertise in major Health Authority interactions.
    • Strong strategic thinking, critical evaluation, and risk management skills.

Preferred Qualifications:

  • Experience leading regulatory teams in high-profile, business-critical programs.
  • Strong oral and written communication skills with the ability to influence stakeholders.
  • Knowledge of regulatory science innovations and novel regulatory tools.

Why Join AstraZeneca?

At AstraZeneca, we encourage bold thinking and seize opportunities for change. Our dynamic and entrepreneurial environment fosters groundbreaking methods and collaboration across diverse teams. If you're ready to redefine expectations in biopharma and make a meaningful impact, join us in driving life-changing medicines to market.

Diversity & Inclusion Commitment

AstraZeneca is committed to building an inclusive and diverse workforce, ensuring equal opportunities for all candidates. We comply with all applicable laws on non-discrimination in employment and recruitment.

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