Regulatory Affairs Associate I

1 week ago

Bengaluru, Karnataka, India AstraZeneca Full time

Job Title: Regulatory Affairs Associate I

Career Level - C

Introduction to Role:
Join our Biopharmaceuticals R&D team as a Regulatory Affairs Associate I, where you will play a critical role in impacting patients in need. As a specialist, you will assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. This is an opportunity to apply your regulatory domain knowledge, lead continuous improvement of processes and tools/systems, and work independently as an individual contributor.

Accountabilities:
As a Regulatory Affairs Associate I, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will plan, prepare and execute simple submissions, and assist with the preparation and planning of regulatory dispatches. You will also be the interface with Health Authority (HA) for designated regulatory tasks. Additionally, you will provide support across the group for assigned non-drug project roles & responsibilities, contribute to EU-CP Linguistic review, support the Clinical Trials Information System (CTIS) tool throughout the lifecycle of a clinical trial, and much more

Essential Skills/Experience:
- At least science or pharmacy graduate.
- Minimum 2 years of Relevant experience from biopharmaceutical industry, or other relevant experience
- Proficient verbal and written English
- Project Management skills
- Experience in document management and tracking databases

Desirable Skills/Experience:
- Some regulatory/medical/technical experience
- Knowledge of Regulatory business and processes
- Some knowledge of Veeva vault (ERV) for submission, compilation, publishing and approval processes, standards, systems and CTIS tools.
- Experience of working with people from locations outside of India, especially Europe and/or USA
- Good written and verbal communication skills
- Cultural awareness
- Proficiency with common document and clinical trial management tools
- Demonstrate high ability to use digital tools and solutions to support productivity, collaboration and learning.
- Contribute to improving or developing new ways of using digital tools and solutions in the business.
- Understanding of emerging technologies AI, ML etc.
- Ability to work independently and as part of a team
- Continuous Improvement and knowledge sharing focused

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are more than just a pharmaceutical company. We are a community dedicated to transforming drug development strategies into reality. We are committed to delivering life-changing medicines to patients in areas of unmet medical needs. We believe in innovation, creative thinking, and change. We value diversity and encourage original thinking. We are curious by nature, always exploring new ideas and ways of doing things. We are part of the solution, involved in key discussions, and we act as both a drug developer and Regulator. We are striving for technology adoption and automation to drive efficiencies and new innovations. We are committed to finding improvements that will impact patients with serious diseases. Join us in our mission to make AstraZeneca the place to build a career in Regulatory.

Ready to make a difference? Apply now and join us in our journey to discover the next life-changing medicine

Date Posted

18-Jun-2024

Closing Date

24-Jun-2024

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