Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate II Regulatory Affairs
• Support a particular region/s for regulatory affairs (US, EU or EM)
• Manage assigned projects of benefit to therapeutic area teams within the group
• Provide support for the Regional Regulatory Strategy contribution to the Regulatory Team that aligns with regional business needs
• Manage regulatory aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies
• Day to day provision of general assistance to Global Regulatory Lead s (GRL) in the compilation of regulatory dossiers, coordination of marketing applications and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes
• Support for use of regulatory systems (RIMS) and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
• Evaluation of request for new MA registration, planning, coordinating and preparing of post approval regulatory submission dossiers (e.g., Variations Application, Renewal application etc.) and ensuring Regulatory compliance for assigned products.
• Planning, preparation, and submission of Clinical Trial Application (CTA) and IND
• Maintenance of the CTA during the study life cycle (e.g. amendments, end of trial notifications, DSURs and Clinical Study Reports) and communication with the relevant HAs (as applicable)
• Support dossier QC, gap analysis & anticipated health authority query tracker and coordination between stake holders.
• Regulatory inputs, contribution & review of the PBRER/ PSUR, PADER, DSUR, US-AR, RMP etc..
• Lead for preparation of responses to HA queries received from Regulatory Agencies
• Review of Core Safety Information (CSI)/ Core Data Sheet (CDS)
• Impact assessment of procedures like Article 31, Article 46, PSUR Assessments, new class label on Product Information/label
• Author and Maintain Regulatory Product profile documents by updating as requested by Global Regulatory Leads (GRL)
• Support GRLs for data analysis, data mining, report generation & data remediation using RIMS & other various Pfizer internal systems.
• Create, maintain and update internal trackers for cluster, product variation trackers etc as requested by GRL s and cluster group
• Upload on going clinical study documents into Pfizer Trial Master file as requested by GRLs.
• Support for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product) by preparing label comparison documents
• Complete data entry for RIMS updates as needed based on email template from Regional Regulatory Leads
• Prepare label chronology document for Pfizer products as requested by GRLs
• Prepare draft meeting notes, archiving meeting minutes and action item lists for Labeling and Rapid Response Team (RRT) meetings as needed
Post Graduate in Pharmacy or Science. 3 to 6 years of experience preferred. Required – excellent written, listening and verbal communication skills, ability to problem solve, technical aptitude ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with appropriate level of supervision, experience in customer service environment, aptitude in project management and logistics
Experience : 3 to 6 years
Qualification : M.Pharm, M.Sc
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th February, 2022
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