Regulatory Affairs Associate I-locations India – Bangalore
The Regulatory Affairs Specialist I, assists 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. The Regulatory Affairs Specialist I is an individual contributor who applies regulatory domain knowledge, may work under limited supervision, and participates in continuous improvement of process and tools/systems.
- 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 biopharmaceutical industry, or other relevant experience
- Proficient verbal and written English
- Project Management skills
- Experience in document management and tracking databases
- 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
- Direct Reports – None
- Indirect Reports -None
Office Working Requirements
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.
SO, WHAT’S NEXT?
· Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
· Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
· If you’re curious to know more then please click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/
Inclusion & Diversity: https://careers.astrazeneca.com/inclusion-diversity
Career Site: https://careers.astrazeneca.com/