Infoclin Consultancy Kolkata is hiring Senior Executive Regulatory Affairs in Clinical Research

Infoclin Consultancy Kolkata is hiring Senior Executive Regulatory Affairs in Clinical Research

8 June, 2022

Job location : Kolkata

Job Description includes
 Updating self with New Drug CT rule_2019
 Reviewing of SOP of clinical trial sites
 Quality control tasks on submission components
 Proficiency with ICH-GCP guidelines
 Under supervision, adherence to project milestones and timelines
 Contributing to departmental initiatives
 Working with team leader to establish individual goals to meet project timelines.
 Providing timely communication on status and /or issues pertaining to Clinical research
 Knowledge of submission dossier to CDSCO
 Paying attention to details for accomplishing publishing tasks
 Having industry knowledge; understanding of industry, FDA requirements
 With guidance, creating and maintaining project documentation including: meeting agendas, meeting
 Minutes of meeting, issues and status reports internally and externally.
 Performing relevant duties for projects as assigned.
 SAE reporting

Qualification: M.Pharm, M.Sc, PharmD
Experience required: 0 – 1 year ( only relevant experience will be counted)

Salary: No bar for right candidate
The job incumbent must be flexible to travel if needed.

Notice period: Immediate to 15 days Maximum

Interested candidates kindly post across updated CV at hr@infoclinconsultancy.com

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