Job Title: Regulatory Affairs Specialist
About AstraZeneca: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies — we are a place to grow, learn, and pioneer the future of healthcare.
Position Purpose:
Monitor and promptly report the status of all product licenses.
Implement submission plans for new products and maintenance of existing products (licenses, amendments, updates) as approved, ensuring timely delivery.
Collate, communicate, and prepare responses for Health Authorities’ queries.
Perform archival tasks and update submission trackers consistently.
Internal Customers:
Marketing
Sales
Logistics
Medical
Legal Affairs
Intellectual Property
Clinical Operations
Global Product Teams (GPTs)
Key Brand Teams (KBTs)
International Regulatory Affairs (IRA)
Manufacturing Sites
Quality Assurance (QA)
Regional Office
External Customers:
CDSCO Office
NIB
IPC
CDTL
CDL
NCB & DCK
Other Local Health Authorities and Government Agencies
Minimum Requirements:
M.Pharm/B.Pharm/M.Sc
3–6 years of experience in India Regulatory function
Knowledge of dossier compilation
Familiarity with Indian regulatory frameworks and requirements
Key Result Areas/Outputs:
Ensure adherence to AstraZeneca and industry codes of conduct, ethics, and good regulatory practices.
Complete all licensing processes for assigned products in accordance with applicable norms.
Develop and implement regulatory action plans for new product approvals to facilitate rapid launches.
Evaluate the impact of new regulatory guidelines in collaboration with Regulatory Affairs leadership.
Support regulatory competitive intelligence and analysis initiatives.
Monitor the status of product licenses and project manage licensing changes.
Maintain complete and up-to-date documentation and submission trackers.
Communicate license status changes promptly to relevant stakeholders.
Maintain detailed knowledge of critical product aspects, including commercial strategies, dossier content, regulatory timelines, and supply strategies.
Implement regulatory strategy plans for new launches, ensuring alignment with stakeholders.
Track regulatory submission status and take corrective measures to ensure timely approvals and launches.
Ensure compliance with internal and external norms for commercial and clinical trial submissions with minimal supervision.
Support internal and external audits.
Support deviation management and CAPA processes.
Ensure timely submission and renewal of import registrations and production transfers to maintain business continuity.
Support artwork reviews and local FDA licensing requirements.
Handle submissions, reviews, and query responses for global clinical trials, Phase IV, and PMS studies, including SEC preparation.
Manage regulatory compliance throughout study conduct, including renewals and amendments, until study closure with minimal supervision.
Why AstraZeneca? At AstraZeneca, we are dedicated to being a Great Place to Work. We empower you to push scientific boundaries and unleash your entrepreneurial spirit. Our inclusive culture champions diversity, collaboration, and a commitment to lifelong learning, growth, and development. Join us on an exciting journey to pioneer the future of healthcare.
Diversity and Inclusion: AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing a wide range of backgrounds and perspectives. We welcome and consider applications from all qualified candidates, complying with all applicable laws and regulations regarding non-discrimination and employment eligibility.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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