Intas Pharmaceuticals | Manager/Sr. Manager
1 month ago
Qualifications: Science Graduate/Postgraduate (Pharmaceutical/Biotechnology Domain)
Experience: > 10 years of experience including team handling experience in similar domain
Job Responsibility:
- Preparation and submission of applications and dossier for registration of recombinant products (innovative and biosimilars), CGT products in India (own manufacturing as well as import registration).
- Preparation and submission of dossier to RCGM for approval of PCT application (dept of Biotechnology).
- Responsible for IBSC (institutional biosafety committee) meeting conduction and related regulatory activities.
- Review and timebound submission of application for MAA, PAC, CT (Phase I, II and Phase III applications), Form 11, Form CT-10, Form CT-16, Dual Use NOC to obtain relevant DCGI approvals.
- Review and timebound submission of application for (GMP inclusion/ renewal of manufacturing license, COPP, FDCA application to obtain relevant FDCA approvals.
- Preparation of draft label for domestic market as per D&C Act.
- Updating, preparing and review of the dossier and documents as well as responses to the queries raised by regulatory agencies for India market.
- Imparting training for preparation of documents and guidance to subordinates.
- Co ordination with internal and external stakeholders for successful regulatory approval of the products.
- Additional Responsibilities: - A. Keep up to date with the current regulatory guidelines and regulatory approval system B. Maintaining/approving of Regulatory & QA documentation C. Any other responsibility assigned by the management.
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Intas Pharmaceuticals | Manager/ Senior Manager
2 months ago
india Intas Pharmaceuticals Full timeWe Are: Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and...
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Intas Pharmaceuticals | Manager/Sr. Manager
1 month ago
india Intas Pharmaceuticals Full timeQualifications: Science Graduate/Postgraduate (Pharmaceutical/Biotechnology Domain) Experience: > 10 years of experience including team handling experience in similar domain Job Responsibility: Preparation and submission of applications and dossier for registration of recombinant products (innovative and biosimilars), CGT products in India (own...
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Intas Pharmaceuticals | General Manager
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Intas Pharmaceuticals | Manager
1 month ago
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Intas Pharmaceuticals | Manager
1 month ago
india Intas Pharmaceuticals Full timeJob ResponsibilityPreparation and updating of Country wise Portfolio Trackers, Monthly update to Countries on Portfolio and discussion with Cross functional teamsManaging MIS and Dashboards for time to time Portfolio update to the management for various meetings including MRM, QRM.Leverage existing knowledge management systems and ensure availability of...
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Intas Pharmaceuticals | Manager
1 month ago
india Intas Pharmaceuticals Full timeJob Responsibility Preparation and updating of Country wise Portfolio Trackers, Monthly update to Countries on Portfolio and discussion with Cross functional teams Managing MIS and Dashboards for time to time Portfolio update to the management for various meetings including MRM, QRM. Leverage existing knowledge management systems and ensure availability of...
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Intas Pharmaceuticals | Executive/Sr. Executive
1 month ago
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Intas Pharmaceuticals | Executive/Sr. Executive
1 month ago
india Intas Pharmaceuticals Full timeJob Overview: Under supervision by the Associate Director, Quality Assurance Nordic & Baltics: Support Quality Assurance team at local affiliate with wholesale activities within Nordic and Baltics. Ensure compliance with GDP and GMP as applicable. Responsibilities: Duties are delegated by Accord Healthcare AB and Accord Healthcare OY’s designated...
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1 day ago
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Intas Pharmaceuticals | Senior Executive
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