Are you looking to advance your career in the pharmaceutical industry? AstraZeneca, a global leader in biopharmaceuticals, is hiring a Regulatory Affairs Associate (RAA) for its Bangalore, India location. This is a full-time position with an application deadline of April 18, 2025. If you have a passion for regulatory affairs and want to contribute to life-changing medicines, this is your opportunity to join a world-class team.
Job Description
As a Regulatory Affairs Associate (RAA), you will play a pivotal role in supporting the Regulatory Affairs Management (RAM) and Regulatory Therapy Area (TA) teams. Your primary responsibilities will include:
- Document Management: Uploading and tracking regulatory files and systems in compliance with AstraZeneca standards and regulatory requirements.
- Regulatory Submissions: Assisting in the planning, preparation, and implementation of regulatory submissions and dispatches.
- Health Authority (HA) Collaboration: Working with Health Authorities and their systems for tasks such as managing user fees, handling FDA correspondence, ordering EudraCT numbers, and using HA portals like CTIS.
- Regulatory Requirements: Ordering and tracking specific regulatory needs, including registration samples, Certificates of Pharmaceutical Product, and legal documentation like Letters of Authorization and Powers of Attorney.
- Non-Drug Projects: Supporting non-drug projects by acting as a point of contact or superuser.
- Team Collaboration: Providing coaching, mentoring, and knowledge sharing within the RAM skill group.
- Process Improvement: Contributing to the enhancement of regulatory processes.
Essential Skills and Experience
- A relevant qualification in science, administration, or IT.
- Experience in the biopharmaceutical industry or a related field.
- Proficiency in verbal and written English.
- Strong project management skills.
- Experience with document management and tracking databases.
Desirable Skills and Experience
- Some regulatory, medical, or technical experience.
- Knowledge of AstraZeneca’s business processes.
- Familiarity with submission, compilation, publishing, and approval processes.
- Basic understanding of the Oncology therapy area.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines. Our innovative approach drives us to think broadly about preventing and treating diseases, making a real difference in patients’ lives.
