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RA_Labelling

1.00 to 5.00 Years   Mumbai City   09 Nov, 2022
CERENTRAL CONSULTANTS PVT LTD Hiring For Client of Cerentral
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Prepare and update the label/ Monograph as per the requirement in New Drug development orProduct lifecycle maintenance in US and Canada market. Prepare and submit all the supporting documents for labelling submissions as per the type ofsubmission for US and Canada Market. Co-ordinate with POC/ Vendor for Artwork creation and update. Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.) Perform ESG submissions and maintain the acknowledgments. Author the responses and be a decision maker for the changes applicability in the labels Define the priority of the labeling requirements and plan the submission based on priority. May provide input and feedback to departmental process improvement strategy discussions Contributes to the creation and promotion of an environment of teamwork ensuring excellencein customer service through the timely delivery of quality drug safety data. Liaises regularly and develops strong working relationship with external partners andinternational company affiliates and demonstrates corporate values in the performance of workand in all interactions with others. Maintains user-level knowledge of labelling softwares Interacts with other internal departments when necessary. Shows initiative to remain current on new labelling regulations and international guidelines andseeks guidance from Leader and management to enhance knowledge. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Courage, Collaboration, Perseveranceand Passion demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safetyrequirements. All other duties as assigned.

Keyskills :
regulatory affairscanadalabelling

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