Senior Executive Dishman Carbogen Amcis Ltd

3.0 - 7.0 years

0 Lacs

gujarat

On-site

As a Senior Executive at Dishman Carbogen Amcis Limited, your primary role will involve preparing DMF / ASMF / CEP dossiers in accordance with the ICH M4 CTD/eCTD guidelines. You will also be responsible for responding to queries from regulatory agencies and customers, preparing Applicants Part of ASMF as per customer requirements and restricted part of ASMF as per regulatory requirements. It will be your responsibility to initiate activities for timely notification or prior approval from regulatory agencies in case of any necessary changes to existing DMF / ASMF / CEPs on an ongoing basis. Key Responsibilities: - Prepare DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines - Respo...

Posted 1 week ago

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Senior Executive Dishman Carbogen Amcis Ltd

5.0 - 9.0 years

0 Lacs

gujarat

On-site

Role Overview: As a Senior Executive at Dishman Carbogen Amcis Limited in Bavla, Gujarat, you will be responsible for preparing DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines. You will also handle responses to queries from regulatory agencies and customers, prepare Applicants Part of ASMF based on customer requirements, and manage renewals and revisions for CEPs / annual reports for USDMFs / ASMF variations. Additionally, you will stay updated on global regulatory requirements, evaluate change control applications for regulatory implications, and provide regulatory input for analytical method validation reports and stability protocols. Key Responsibilities: - Prepare DMF / AS...

Posted 2 months ago

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Assistant Manager/ Manager Regulatory Affairs Emcure Pharmaceuticals Limited

7.0 - 11.0 years

0 Lacs

pune, maharashtra

On-site

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing chang...

Posted 5 months ago

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