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?
- 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.
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
- 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.
- 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
- 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!
