AstraZeneca Regulatory Affairs Associate I Job Recruitment
Regulatory Affairs Associate I
India – Bangalore
Time Type: Full time
Posted on: Posted Today
Job Requisition ID: R-181482
About AstraZeneca
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society. We have an inclusive culture that champions diversity and collaboration, always committed to lifelong learning, growth, and development.
About the Team
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function, we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
About the Role
Description:
The Regulatory Affairs Specialist I assists other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The Regulatory Affairs Specialist I is an individual contributor who applies regulatory domain knowledge, may work under limited supervision, and participates in the continuous improvement of
process and tools/systems.Accountabilities/Responsibilities:
- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
- Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches
- Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals
- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
- Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
- Provide guidance and knowledge sharing within the RAM skill group
- Contribute to process improvement
Minimum Requirements – Education and Experience
- Relevant qualification and/or experience in science
- Minimum of 2 years of relevant experience from the biopharmaceutical industry, or other relevant experience
- Proficient verbal and written English
- Project Management skills
- Experience in document management and tracking databases
Preferred Experience
- Some regulatory/medical/technical experience
- Experience of regulatory information management database
- Knowledge of AZ business and processes
- Some knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems, and tools
- Experience of working with people from locations outside of India, especially Europe and/or USA
Skills and Capabilities
- Good written and verbal communication skills
- Cultural awareness
- Proficiency with common document management tools
- Ability to work independently and as part of a team
- Continuous improvement and knowledge sharing focused
Internal and External Contacts/Customers
- Lead RPM and members of the GRET and GRST
- Other R&D skill groups, e.g., GRO, GLG, Reg CMC, Operations Regulatory, PS, Reg TA (GRL & Regional Leads)
- Marketing Companies
- Health Authorities
- External collaboration partners
- AstraZeneca Legal
Reporting Relationship
Direct Reports – None
Indirect Reports – None
Link to Original Notification to apply: Apply Here
