Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Senior Executive Dishman Carbogen Amcis

3.0 - 5.0 years

5 - 9 Lacs

bavla

Work from Office

Title: Senior Executive Custom Field 2: 2660 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines, Preparation of response to queries raised by various regulatory agencies & customer, Preparation of Applicants Part of ASMF as per customer requirement and restricted part of ASMF as per regulatory requirement, Initiation of activity for timely notification / prior approval from regulatory agencies in case of any changes required to the existing DMF / ASMF / CEP on ongoing basis Initiation & preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations, Keeping update about the current global regulatory requirement Evaluation of change control applications for regulatory implications, Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authoritiesrequ Job Segment: Law, Legal

Posted 3 days ago

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