About AstraZeneca

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

Monitor and promptly report the status of all product licensesImplement submission plan for new products and products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on timeCollates, communicates and prepares for Health authorities’ queriesPerforms archival & update submission trackers

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 and QA, Regional Office.

External customers :CDSCO Office, NIB, IPC, CDTL, CDL, NCB & DCK and other Local Health Authorities and other Government Agencies.

Minimum requirements :M.Pharm/B.Pharm/ M. Sc 3-6 yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be conversant with Indian regulations.

Key Result Areas/ outputs

Adherence to AZ and industry codes of conduct, ethics and good regulatory practicesEnsure that all licensing for assigned products is complete in accordance with relevant normsDevelop and implement action regulatory plans for allocated new products to achieve requisite approvals rapidly and facilitate the rapid launchEvaluates impact of new guidelines in liaison with RA leadershipSupport Regulatory competitive Intelligence and analysisMonitor status of product licensesProject manage changes in product licenses and coordinate with other changes, planned and in progressMaintain complete documentation records and all trackers timely maintainedCommunicate changes to licenses status promptlyMaintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy and proactive preparation of required steps, manages local testing and legal documents for new launchesImplement regulatory strategy plan for new launches in conjunction with key stakeholders and deliver plans on timeTrack status and take prompt corrective measures whenever necessary to ensure rapid approval and launchEnsure timely submission for regulatory compliances for commercial and clinical trials as per external and internal norms with minimum supervision from manager and internal databasesSupport relevant audits internal and externalSupports deviations/ CAPA as neededEnsures timely submission of import registration/ renewal and production transfer to ensure business continuitySupports artworks review and local FDA licenses as assignedHandles submission/ review/ query responses for global clinical trials/ phase IV/ PMS studies including SEC preparationManages regulatory compliance during study conduct including renewal/ amendments and till study closure with minimum supervision from manager.

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.

Date Posted

22-Jan-2025

Closing Date

27-Feb-2025

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.