0.0 years

0 Lacs

vadodara, gujarat, india

On-site

Executive and Sr. Executive Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like China , Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway

Posted 23 hours ago

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Manager - 1 SUN PHARMA

0.0 years

0 Lacs

vadodara, gujarat, india

On-site

Job Description Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, preparati...

Posted 1 day ago

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Manager-Regulatory & Business Continuity - US Market SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Posted 5 days ago

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Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier ...

Posted 2 months ago

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