WhatsApp Group Join Now
Telegram Group Join Now

Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

SHARE

Company: AstraZeneca
Location: Bangalore
Job ID: R-211157
Functional Area: Regulatory Affairs
End Date for Applications: 20th November 2024

About AstraZeneca:

AstraZeneca is dedicated to contributing positively to the UK and global health by providing life-changing medicines. Our commitment extends beyond healthcare; we are invested in job creation and economic development. We continually seek innovative regulatory approaches to expedite the delivery of our therapies to patients worldwide.

Job Description:

We are seeking an International Associate Regulatory Affairs Director I to join our International Regulatory Affairs Management (RAM) team. In this pivotal role, you will work in a dynamic regulatory environment and lead efforts to accelerate the approval of new medicines across international markets.

Key Responsibilities:

  • Provide expert regulatory guidance for efficient international market submissions.
  • Optimize submission strategies for assigned products and markets.
  • Collaborate with teams to address challenges in submission preparation.
  • Share best practices within the RAM community to enhance submission quality.
  • Engage with Regional Regulatory Contacts to leverage insights from submissions.
  • Drive the creation and management of International shared regulatory packs.
  • Develop and maintain strong relationships with stakeholders, ensuring alignment and issue resolution.
  • Contribute to Regulatory Intelligence initiatives, including the Regulatory Requirements Repository (R3).
  • Understand and navigate the regulatory framework for small and large molecules.
  • Lead the planning and execution of complex regulatory submissions.
  • Coordinate and communicate project plans and updates to stakeholders.
  • Identify and mitigate regulatory risks.
  • Coach and mentor team members, promoting continuous improvement.

Candidate Profile:

  • Education: Relevant University Degree in Science or related discipline.
  • Experience: Minimum of 10+ years in regulatory affairs within the biopharmaceutical industry, with extensive experience in international markets.
  • Skills:
    • In-depth knowledge of drug development and international regulatory frameworks.
    • Proven track record of managing complex regulatory deliverables, including new MAAs and license maintenance.
    • Strong project management and stakeholder engagement abilities.
    • Excellent interpersonal and leadership skills, with experience leading cross-functional teams.
    • Proficiency in English and cultural awareness to work effectively across diverse teams.
    • Familiarity with project management and document management tools.
    • Ability to analyze problems and propose actionable solutions.
    • Commitment to continuous improvement and knowledge sharing.

Why Join Us?

At AstraZeneca, you’ll be part of a collaborative team that is making a difference in the lives of patients worldwide. If you are passionate about regulatory affairs and want to contribute to innovative healthcare solutions, we encourage you to apply.

Application Process:

Please submit your application by 20th November 2024. We look forward to seeing how you can make an impact with us!

Application Link

AstraZeneca Hiring International Associate Regulatory Affairs Director