AstraZeneca Hiring Regulatory Affairs Associate - Pharmacy Graduate Apply

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Post : Regulatory Affairs Associate I

Job Description
• 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.

Candidate Profile
• 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
• 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.

Additional Information
Experience : 3-5 years
Qualification : science or pharmacy graduate
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th August 2025