Are you a Regulatory Affairs professional seeking a new challenge? AstraZeneca invites talented individuals to join our team as a Regulatory Affairs Manager I. This is a unique opportunity to contribute to groundbreaking advancements in healthcare and play a pivotal role in ensuring regulatory compliance.
As a Regulatory Affairs Manager I at AstraZeneca, you will be at the forefront of regulatory strategy, navigating the complex landscape of healthcare regulations and driving initiatives that shape the future of medicine. Join a globally renowned pharmaceutical company committed to making a positive impact on patients’ lives.
Position: Regulatory Affairs Manager I
Introduction to role:
The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The Regulatory Affairs Manager I may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Affairs Management, Global Labelling Management and Dossier Management. The Regulatory Affairs Manager I is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).
Accountabilities:
The Regulatory Affairs Manager I is fully proficient in applying established standards to perform regulatory affairs management for simple/moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems.
Essential Skills/Experience:
1. Relevant University Degree in Science or related discipline
2. Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets 3. 3. 3. General knowledge of drug development
4. Thorough knowledge of the regulatory product maintenance process
5. Strong project management skills
6. Leadership skills, including experience leading multi-disciplinary project teams
Desirable Skills/Experience:
1. Regulatory affairs experience across a broad range of markets
2. Managed regulatory deliverables at the project level
3. Experience of working with people from locations outside of India, especially Europe and/or USA
4. Excellent English written and verbal communication skills
5. Cultural awareness
6. Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
7. Proficiency with common project management (e.g., MS Project) and document management tools
8. Ability to work independently and as part of a team
9. Influencing and stakeholder management skills
10. Ability to analyze problems and recommend actions
11. Continuous Improvement and knowledge sharing focused.
Location: Bengaluru
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