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Regulatory Affairs Director Cvrm

3+ years
Not Disclosed
10 Feb. 16, 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

Introduction to Role:
Are you passionate about science and experienced in regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Join us at Cardiovascular, Renal, and Metabolism (CVRM) Regulatory Affairs to contribute to global regulatory strategies and support the research, development, and commercialization of our products across the portfolio.

AstraZeneca’s pipeline of innovative medicines continues to grow within CVRM. Our Regulatory Affairs team employs innovative approaches to bring life-changing treatments to patients efficiently and effectively, working across both early- and late-stage development. We are committed to advancing our products and people by fostering an open and supportive environment for learning and development.

With a presence in over 100 countries and a team of more than 90,000 professionals, AstraZeneca is dedicated to making a positive impact on patients' lives. Our regulatory team in Bangalore is expanding, offering an exciting opportunity for professionals seeking a new challenge in CVRM Regulatory Affairs.

Responsibilities:
As a Regulatory Affairs professional at AstraZeneca, you will play a crucial role in leveraging our scientific capabilities to bring positive change to patients' lives. Our Regulatory Affairs teams shape the development of our pipeline, define regulatory strategies, and engage with Health Authorities to advance our programs.

Key responsibilities include:

  • Defining and implementing global regulatory strategies for assigned products.
  • Providing strategic regulatory guidance to cross-functional teams.
  • Leading regulatory interactions with major health authorities.
  • Ensuring compliance with global regulatory requirements.
  • Contributing to regulatory submissions and approvals.
  • Driving innovation in regulatory approaches to support product development.
  • Collaborating with internal and external stakeholders to optimize regulatory outcomes.

Essential Qualifications & Experience:

  • Bachelor's degree in a science-related field.
  • Minimum of 3 years of experience in regulatory strategy within a pharmaceutical organization.
  • Extensive knowledge of regulatory affairs across therapeutic areas in early and late development.
  • Proven track record in regulatory drug development, including product approval and launch.
  • Experience leading major health authority interactions.
  • Strategic and critical thinking abilities with a risk-evaluation mindset.
  • Strong leadership, communication, and influencing skills.
  • Ability to navigate complex regulatory environments and drive business-critical initiatives.

Why AstraZeneca?
At AstraZeneca, we seize opportunities for change and make them happen. Delivering life-changing medicines requires an entrepreneurial mindset—identifying pivotal moments and recognizing their potential. Join us in redefining what a biopharmaceutical company can be by pioneering new methods, fostering collaboration, and embracing innovation.

Diversity & Inclusion:
AstraZeneca is committed to fostering a diverse and inclusive workforce. We welcome applications from all qualified candidates, ensuring equal opportunities and compliance with employment laws and regulations.

Ready to make an impact? Apply now!