Assistant Manager – Regulatory Affairs

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 licenses
• Implement submission plan for new products and products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time
• Collates, communicates and prepares for Health authorities’ queries
• Performs 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 practices
• Ensure that all licensing for assigned products is complete in accordance with relevant norms
• Develop and implement action regulatory plans for allocated new products to achieve requisite approvals rapidly and facilitate the rapid launch
• Evaluates impact of new guidelines in liaison with RA leadership
• Support Regulatory competitive Intelligence and analysis
• Monitor status of product licenses
• Project manage changes in product licenses and coordinate with other changes, planned and in progress
• Maintain complete documentation records and all trackers timely maintained
• Communicate changes to licenses status promptly
• Maintain 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 launches
• Implement regulatory strategy plan for new launches in conjunction with key stakeholders and deliver plans on time
• Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
• Ensure timely submission for regulatory compliances for commercial and clinical trials as per external and internal norms with minimum supervision from manager and internal databases
• Support relevant audits internal and external
• Supports deviations/ CAPA as needed
• Ensures timely submission of import registration/ renewal and production transfer to ensure business continuity
• Supports artworks review and local FDA licenses as assigned
• Handles submission/ review/ query responses for global clinical trials/ phase IV/ PMS studies including SEC preparation
• Manages 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.