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Project Manager Regulatory Affairs
3 weeks ago
Duties & Responsibilities
Support Regulatory projects and Compliance standpoint on key projects within EM Regulatory groups Management End to End key RA project: acting as project manager & connecting point among key EPD stakeholders within & out of Regulatory groups such as EM Commercial affiliates (Quality & Regulatory functions Prepare powerpoints & Executive presentations for monthly reporting to Senior Leadership Team Effective communication & interpersonal skills with the ability to collaborate with cross functional teams and convey compliance concepts to non technical stakeholders Ability to work collaboratively within a team enviremnment, prioritize tasks & assist in managing multiple project simultaneoustly Solid analytical skills with the ability to comprehend & apply regulatory requirements to operational processes Perform extensive data analysis, generates weekly, monthly reports & trends Preparing RA reports for all regulatory activities (New registrations, renewals, LCM) Monitor timely RA submission & approvals & report all the significant events& changes in the regulatory environmentMaintain an up-to-date database for all submissions
Issuing and updating the SOP in line with Global SOP and Local Regulation in EM countries. Guarantee the compliance with national legislation, international regulatory guidelines and internal requirements. Ensure that the End to End compliance management process is in compliance with the local regulation and global SOP.. Support / execute Audit preparation, Non conformance report and validation CAPA plans Assure Record Management plan for all Regulatory documentation Proven track record of developing 7 implementing compliance program procedures In depth knowledge of regulatory requirements
Experience Required
Education: Chemistry, Pharmacy. Years of Experience: at least 7 years in Regulatory Affairs & RA compliance, data analysis, project Management … Language: Fluent English Location:India Mumbai-
Project Manager Regulatory Affairs
1 week ago
Mumbai, Maharashtra, India Abbott Full timeDuties & Responsibilities Support Regulatory projects and Compliance standpoint on key projects within EM Regulatory groups Management End to End key RA project: acting as project manager & connecting point among key EPD stakeholders within & out of Regulatory groups such as EM Commercial affiliates (Quality & Regulatory functions Prepare powerpoints &...
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