AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
Post : Regulatory Assistant
Job Description
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 coaching, mentoring and knowledge sharing within the RPM skill group
• Contribute to process improvement
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 coaching, mentoring and knowledge sharing within the RPM skill group
• Contribute to process improvement
Candidate Profile
• Relevant qualification and/or experience in science, administration or IT
• 2 - 5 Years’ Relevant experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project Management skills
• Experience in document management and tracking databases
• Relevant qualification and/or experience in science, administration or IT
• 2 - 5 Years’ 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
• Knowledge of AZ business and processes
• Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools
• Experience of working with people from locations outside of India, especially Europe and/or USA
• 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
• 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
• 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
Additional Information
Qualification : Bachelors or Masters Degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Product Regulatory Affairs
End Date : 30th December, 2018
Qualification : Bachelors or Masters Degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Product Regulatory Affairs
End Date : 30th December, 2018
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