AstraZeneca is hiring for the position of Regulatory Affairs Manager I at their Bangalore location. The role involves managing regulatory submissions, maintaining product licenses, and contributing to labeling and documentation requirements. You would work closely with cross-functional teams and regulatory authorities to ensure compliance and facilitate product approvals.
Job Title: Regulatory Affairs Manager I
Career Level – D
Locations: India – Bangalore
Introduction to Role:
Are you ready to take on a role that lets you flex your regulatory expertise and project management skills? As a Regulatory Affairs Manager I at AstraZeneca, you’ll be a key player in our Global Regulatory Execution Team (GRET), taking on responsibilities in Regulatory Affairs Management, Global Labelling Management, and Dossier Management. You’ll be working in a dynamic environment, leading cross-functional activities and contributing to the continuous improvement of our processes and tools.
Accountabilities:
In this role, you’ll be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This includes contributing to regulatory submission strategy, identifying submission risks and opportunities, and managing procedures through approval. You’ll also provide regulatory expertise and mentorship on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams.
Essential Skills/Experience:
- Relevant University Degree in Science or related field
- Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry
- Detailed knowledge of the regulatory product maintenance process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams.
Desirable Skills/Experience:
- Regulatory affairs experience across a broad range of markets
- Led regulatory results at the project level
- Experience of working with people from locations outside of India, especially Europe and/or USA
- Excellent English written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project) and document management tools
- Ability to work independently and as part of a team
- Influencing and stakeholder leadership skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused.
Date Posted 26-Sept-2024
Closing Date 29-Sept-2024
