Regulatory Affairs Associate I

Job Title Regulatory Affairs Associate I Global Career Level C1 Introduction to role Are you ready to be part of the solution turning drug development strategies into reality As a Regulatory Affairs Associate I you ll play a crucial role in obtaining and maintaining licenses and applications ensuring they align with AstraZeneca s standards and regulatory strategies This position offers the opportunity to work independently apply your regulatory domain knowledge and lead continuous improvement of processes and tools Are you prepared to make an impact Accountabilities 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 For US cross GRET activities- Apostille legalization of CPPs Interface on FDA payments- user fees-across TAs-NDA BLA Annual payments for FDA Priority review voucher US simple submissions Updating US signatories Be the interface with Health Authority HA and its systems for designated regulatory tasks For EU cross GRET activities- ordering EudraCT number EudraLink support Co-ordinating EMA Linguistic reviews Ordering CPPs MPA MHRA EMA - Certificates of Proof of Establishment Certificates of Registrations Good Standing plus uploading into ERV IRIS administrator - EMA system for Scientific Advice ODD GMP PV GCP inspections 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 Support the Clinical Trials Information System CTIS tool throughout the lifecycle of a clinical trial Submit DSUR submission for outsourced trials on CTIS Uploading regulatory documents to eTMF and carrying out quarterly QC checks for assigned studies Act as Veeva regulatory vault ERV tool support to RAMs Act as Veeva clinical vault VCV tool support to RAMs Provide guidance and knowledge sharing within the RAA RAM skill group Contribute to process improvement Support GRET RAM and LRPM on any operational tasks Audit Support and Tender Support to GRET Essential Skills Experience Minimum Requirements -Education and Experience At least science or pharmacy graduate Minimum 3-5 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 Skills and Capabilities Knowledge of Veeva regulatory vault VRV Veeva clinical vault VCV 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 Flexible to work outside India time zone with the EU and US stakeholders as and when needed Internal and External Contacts Customers Lead RPM GRET RAM and members of the GRET and GRST Regulatory skill groups in TAs- Late CVRM International ORSSE Late R I and V I Other R D skill groups e g Clinical Clinical Operations GRO Labeling Reg CMC Operations regulatory Patient Safety Regulatory Central GRL Trial group Regional Leads etc Marketing Companies Health Authorities External collaboration partners AstraZeneca Legal Reporting Relationship Direct Reports - None Indirect Reports -None 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 thrive on innovation and collaboration Our diverse team is empowered to make quick decisions and influence drug development strategies across all levels We are committed to finding improvements that impact patients with serious diseases by asking questions and trying new things With a science-driven approach we bring life-changing medicines to patients while supporting your professional growth through our Regulatory academy Ready to take on this exciting challenge Apply now to join our dynamic team Date Posted 24-Jul-2025 Closing Date 29-Jul-2025 AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills We believe that the more inclusive we are the better our work will be We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment and recruitment as well as work authorization and employment eligibility verification requirements