Regulatory Affairs Associate at AstraZeneca

The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards.

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 Authorization, 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 coaching, mentoring and knowledge sharing within the RAM skill group.
Contribute to process improvement.

Minimum Requirements

Associate's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
1 - 3 years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
Relevant experience in science from biopharmaceutical industry, or other relevant experience
Proficient verbal and written English
Project Management skills
Experience in document management and tracking databases

Preferred Experience

Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
3+ years of experience in Regulatory / Drug Development
(Industry or Health Authority) 1+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
Some regulatory/medical/technical experience
Knowledge of AZ business and processes
Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools

Skills and Capabilities

Good written and verbal communication skills
Cultural awareness

Regulatory Affairs Associate

About This Role

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