Regulatory Affairs Pharma Associate Post 2022 Announced – Pfizer

Regulatory Affairs Pharma Associate Post 2022 Announced – Pfizer

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and the potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Job Title: Associate II Regulatory Affairs

Location: India – Chennai

Education: Post Graduate in Pharmacy or Science. 3 to 6 years of experience preferred.

Skills 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 an appropriate level of supervision, experience in a customer service environment, aptitude in project management and logistics

Job Summary: 

• 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.

Job Responsibilties: 

• 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 stakeholders.
• 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 the cluster, product variation trackers etc as requested by GRL s and cluster group
• Upload ongoing 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

Apply Online

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