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Job Id
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202207
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Title
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Jr Regulatory Affairs Executive
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Job Type
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Permanent
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Duration
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City
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State
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Telangana
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Zip
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Job Description
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Company DescriptionMakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion. MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job Description: Jr Regulatory Affairs Executive
- Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets.
- Publishing electronic regulatory submissions (eCTD):
- Submission build activities, creating inter-document links, performing a quality checks and validating compiled submissions, and finalizing submission by the required dispatch date.
- Coordination with the team for timely submissions.
- Reviewing manufacturing documents like MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol and PDR.
- Preparation and review of the response to the Agency's queries and submission within the stipulated time given by health authorities.
- To develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
RequirementsA minimum of 0.6 months - 2 years of experience with eCTD and Publishing in Regulatory - CRO or Biopharma industry side.
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Qualification
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Certification/Licensure
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Experience
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0-2
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Job Category
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Regulatory
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Posted On
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7/22/2022
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Expires On
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8/22/2022
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