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Job Opening details:-
Company Name :- AstraZeneca
Position Name :- Manager – GxP & Regulatory
Company Location :- Bengaluru, Karnataka
Job Category :- Management jobs
Full Job Description :-
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Making the impossible a reality can mean taking a chance on an idea and investing in our exceptional capacity for innovation and discovery. We champion trying new things, and we nurture a test and learn culture that means we are always progressing close to our goals. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Report issues (quality, compliance, deviations etc) using Veeva Quality vault (VQV) tool.
Creating self-assessment plan for GxP areas including GVP, GMP-GDP, QMS, GRP
Establish the change management process for Asia Area Frontier Markets (AAFM) including maintaining change log
Create Quality manual for AAFM
Report risk using risk register tool
Review local training plan process including allocation of Job Roles, CVs & Job descriptions, review of Induction Program to cover all GxP areas
Create a Business Continuity Plan (BCP) for all GxP areas
Review Document management process including Global Retention and Disposal (GRAD) requirements
Submission of annual GxP checklist
Uploading the GxP document on First Doc
Additional responsibility to create Quality Assurance Agreement for Maldives and Brunei
Dossier compilation as per the TOC
Follow up with Partner to ensure timely submission
Ensure the submission/query/ additional requested by HA etc. should be informed to our global colleagues through system viz., filing, creating doc ID etc.
Support to Regulatory dossier preparation and Submission like New drug application, Site registration and Import License. Managing Registration sample right from dispatch of samples till the report.
Maintaining License life cycle management with tracker, to ensure License is valid
Regulatory intelligence information
HA submitted information maintenance
Ensure high standard of regulatory compliance, to achieve the company’s business objectives
Vaccine Related KPIs:
Digital readiness for launching AZ COVID vaccine including vaccine website, telephony set up for Brunei and Maldives
Preparing and updating PI and PIL for local markets in line with the global Core data sheet
Creating Risk management plan for local markets
Customizing the training guides for HCP and Patients
Work Location – Bangalore
Experience – 6+ years
Conversant and relevant experience with Indian regulations related to New product registration, Mfg site registration, Import of new drugs and Clinical trial regulations
Function specific as well as overall Pharmaceutical industry knowledge
Ability to build stakeholder relationships
Strong negotiation and advisory skills
Analytical mindset and knowledge management
Passion for Regulatory Affairs and collaborative working style
Ability to drive performance and act decisively
Knowledge of the latest technical and regulatory developments
People and organization development ability
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
If you’re curious to know more then please apply to this post and we will revert back to you.
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