AstraZeneca- Apply for Regulatory Affairs Specialist I position
Regulatory Affairs Specialist I
JOB TITLE: REGULATORY AFFAIRS SPECIALIST I
CAREER LEVEL: C
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..
About The Role
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
Minimum Requirements –Education And Experience
Relevant qualification and/or 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
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