
Officer/Executive - Regulatory Affairs
2 weeks ago
Role & responsibilities
- Responsible for activities related to US/EU market.
- Prepare the registration dossiers as per regulatory guidelines.
- Submitting GCC dossiers, variations, and query responses through eCTD software.
- Ensure timely preparation of the agency's query responses to expedite approvals.
- Prepare and submit post-registration variations application, Involved in the renewal process of drug registration.
- Review technical documents on receipt from various departments before inclusion in various applications and dossiers.
- Maintenance of the regulatory database for the US market.
- Product Lifecycle Management .
- Discuss and coordinate with cross-functional teams like QA, QC, R&D, Analytical, marketing,
- manufacturing plant, administrative dept., etc. for finalization of documents and with API vendor for getting DMF, LOA, CEP, and other API-related documents .
- Responsible for getting the FDA-approved documents legalized such as Notary, Chamber, Apostille, Embassy, etc.
- Responsible for sending the hard copies of documents, samples, columns, impurities, placebo, etc. to respective countries of evaluation
- Being updated with relevant regulatory guidelines.
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Regulatory Affairs
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Regulatory Affairs
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Regulatory Affairs Specialist
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Executive Regulatory Affairs
1 week ago
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Regulatory Affairs-CMC
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Regulatory Affairs Professional
2 weeks ago
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Regulatory Affairs Expert
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Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Job Title: Regulatory Affairs Specialist Objective:The ideal candidate will prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.Key Responsibilities:Screen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile,...
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Regulatory Affairs Specialist
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Required Regulatory Affairs
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Regulatory Affairs CMC Associate
2 weeks ago
Mumbai, Maharashtra, India Ztek Consulting Full timeJob Description – Regulatory Affairs CMC Associate (US Market) We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities. Key Responsibilities: Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format....