AstraZeneca Job Vacancy For Regulatory Affairs Specialist Position

●JOB TITLE: REGULATORY AFFAIRS SPECIALIST

●Description:-

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.

●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 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

●Qualification And Experience:-

▪︎Relevant qualification and 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

▪︎Preferred Experience

▪︎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

●Apply Now

AstraZeneca Job Vacancy For Regulatory Affairs Specialist Position