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!