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AstraZeneca looking for Regulatory Affairs Associate


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AstraZeneca looking for Regulatory Affairs Associate

AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.

Post : Regulatory Affairs Associate I

Job Description
Brief Job Description
The Regulatory Affairs Associate I assist 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 Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision.

Accountabilities / Responsibilities
• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
• Planning, preparing and completing simple submissions, and assisting with the preparation and planning of regulatory dispatches
• Be the talk to health authority (HA) and their 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, power of attorney, translations of regulatory documentation
• Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser
• Provide guidance and knowledge sharing within the RAM skill group
• If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc.

Candidate Profile
• Relevant qualification and/or experience in science
• Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project management skills
• Experience in document management and tracking databases.
• Some regulatory/medical/technical experience
• Knowledge of AZ business and processes
• Some knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems and tools
• Experience of collaborating with people from locations outside of India, especially Europe and/or USA.
• Good written and verbal communication skills in English
• Cultural awareness
• Proficiency with common document management tools
• Ability to work independently and as part of a team
• Focus on continuous improvement and knowledge sharing.

Additional Information
Experience : 2 years
Location : Bangalore
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 10th October, 2023

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