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  • CMC (Module 2 & 3) content development & regulatory writing for rDNA biosimilar submissions. Preparation of paper based e-CTD based CC packages.Thorough understanding of regulatory guidance's as applicable for CMC requirements of ICH, EMA, USFDA. Regulatory experience of handling CMC content preparation is desired for the incumbent. Experience of CMC content development as per CDSCO/ICH/EMA/FDA ...

  • 1. Preparation, compilation and review of pharmaceutical dossiers. 2. Execute all activities necessary for the smooth compilation of dossier submission. 3. co ordinate to have the Embassy and other Attestations of the legal documents ...

  • Regulatory Affairs: Technical Regulatory work for various countries like All Africa, Asian Countries. Interacting with regulatory authorities for approvals of new & existing applications as well as reviewing & preparing amendments for deficiencies. Handling analytical work & documentation as per Post: Regulatory Affairs/ Officer (Pharma) Copany Profile: Pharmaceutical Industry. Job Location: Thane (W). Age Limit: Up ...

  • at Pre- construction, during construction and post construction stage for Real Estate Projects Handling and maintaining relations with the Politicians Attending Managements review meetings. Due diligence for new projects Candidate Must have experience in Real Estate Liaisoning with Top Level ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • knowledge of global and Indian regulatory requirements 3 - 5 years in regulatory affairs in apharmaceutical industry in an MNC. inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs ...

  • Develop/Review content and format for regulatory submissions for investigational new drugs/ clinical trial applications and related supplements / amendments for completeness and compliance Experience in Global Regulatory submissions (For NCE) e.g. India DCGI, US-IND, EU-CTA filings Detailed knowledge of ICH, EU and FDA regulations and guidance for drugs Understanding of non-clinical / clinical sections of ...

  • Develop/Review content and format for regulatory submissions for investigational new drugs/ clinical trial applications and related supplements / amendments for completeness and compliance Experience in Global Regulatory submissions (For NCE) e.g. India DCGI, US-IND, EU-CTA filings Detailed knowledge of ICH, EU and FDA regulations and guidance for drugs Understanding of non-clinical / clinical sections of ...

  • Develop/Review content and format for regulatory submissions for investigational new drugs/ clinical trial applications and related supplements / amendments for completeness and compliance Experience in Global Regulatory submissions (For NCE) e.g. India DCGI, US-IND, EU-CTA filings Detailed knowledge of ICH, EU and FDA regulations and guidance for drugs Understanding of non-clinical / clinical sections of ...

  • Write high quality deficiency response to various regulatory authorities. · Knowledge of commercial regulatory requirements for all the regulated markets. · Should have knowledge of registration process , plant audits. · Compilation & review of dossier including technical Please refer the given job description for detailed information

  • CMC (Module 2 & 3) content development & regulatory writing for rDNA biosimilar submissions. Preparation of paper based e-CTD based CC packages.Thorough understanding of regulatory guidance's as applicable for CMC requirements of ICH, EMA, USFDA. Regulatory experience of handling CMC content preparation is desired for the incumbent. Experience of CMC content development as per CDSCO/ICH/EMA/FDA ...

  • OnDemand (the Firms learning management system) - Develop/manage a regular internal training series for the Financial Crimes Group for APAC - Work with APAC Financial Crimes coverage teams to develop training content - Assist in the development of the AML Groups annual targeted training plan for APAC ...

  • OnDemand (the Firms learning management system) - Develop/manage a regular internal training series for the Financial Crimes Group for APAC - Work with APAC Financial Crimes coverage teams to develop training content - Assist in the development of the AML Groups annual targeted training plan for APAC ...

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