About AstraZeneca Bangalore :
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines. Our Purpose is to push the boundaries of science to deliver life-changing medicines. We believe the best way we can achieve our Purpose is to put science at the centre of everything we do. Science defines who we are. It is why we come to work every day and is part of our DNA. But this is only half of the story.
We know that we do not have all the answers. We want to share ideas because we believe it results in better medicines. We want the way we work to be inclusive, open and collaborative. This approach runs through all that we do. We focus on three main therapy areas – Oncology, Cardiovascular & Metabolic Disease (CVMD) and Respiratory – and we are also selectively active in the areas of autoimmunity, neuroscience and infection.
To put ourselves in the best position to push the boundaries of science, we seek to leverage our combination of capabilities, which encompass both small molecules and biologics, and include immunotherapies and developing innovative delivery devices that can offer choices to patients. These are reinforced by a strong focus on personalized healthcare capabilities, which aim to match medicines only to those patients who will benefit from them.
Our teams also work alongside the world’s leading academic and biotech research institutions to stimulate innovation and evaluate emerging technologies such as Modified RNA and CRISPR genome editing. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, visit www.astrazeneca.com.
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About AstraZeneca Job Openings In Bangalore:
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 a 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 the 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 the continuous improvement of processes 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 the 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 Products, 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 the 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
