AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Position purpose
For assigned products: Developing India-specific Artwork, Support Regulatory dossier preparation and Submissions like New drug applications, Site registration, clinical trial and Import licence. Managing Registration samples right from dispatch of samples till the report. Licence Life cycle management. Adequate representation in SEC
Internal customers
Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA, Regional Office
External customers
CDSCO Office, NIB, IPC, CDTL, CDL, NCB & DCK and other Local Health Authorities and other Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals
Minimum requirements
Qualification: M.Pharm/B.Pharm/ 6-10yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be conversant with Indian regulations.
Key Result Areas/ outputs
Key Result Areas/outputs
Activities
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
Key Result Areas/outputs
Ensure that all licensing for assigned products is complete in accordance with relevant norms
Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
Provide Leadership and direction within project teams
Assist in Issue Management
Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio
Competitive Intelligence and Analysis
Why AstraZeneca?
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.
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Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
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Date Posted
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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