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AstraZeneca

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4.1

based on 808 Reviews

1 AstraZeneca Assistant Manager Regulatory Affairs Job

Assistant Manager - Regulatory Affairs

AstraZeneca India Pvt. Ltd

4.1

based on 808 Reviews

3-6 years

Bangalore / Bengaluru

1 vacancy

Assistant Manager - Regulatory Affairs

AstraZeneca

posted 7d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Legal Logistics Healthcare Recruitment Clinical Trials

+ 4 more

Job Description

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.