Senior Executive
7 days ago
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 Applicant's 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 authorities' requ
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Senior Executive
7 days ago
Bavla, Gujarat, India Dishman Carbogen Amcis Ltd Full time ₹ 5,00,000 - ₹ 10,00,000 per yearTitle: Senior Executive - APICustom Field 2: 2751Location:Bavla, Gujarat, INCountry/Region: INState: GujaCity: BavlaCompany: Dishman Carbogen Amcis LimitedBusiness Unit: GeneralTravelDescription:Ensuring that analytical methods are validated and verified in compliance with regulatory standards.Reviewing and approving validation protocols and reports to...
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Bavla, India Dishman Carbogen Amcis Ltd Full timeTitle: Senior Executive - API Custom Field 2: 2751 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General TravelDescription: Ensuring that analytical methods are validated and verified in compliance with regulatory standards. Reviewing and approving validation protocols and...
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7 days ago
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