Regulatory Affairs Executive job openings in Hyderabad

Regulatory Affairs Executive job openings in Hyderabad

Regulatory Affairs Executive job openings in Hyderabad by makrocare group

MakroCare 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

Job Description: Regulatory Affairs Executive

  • Preparation, Review, and submission of Technical documents (CTD/eCTD/ACTD) for Devices of Regulatory and Non Regulatory Markets.
  • Submission builds activities, creating inter-document links, performing 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, MDR/IVDR/IVD 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.

Requirements

  • A minimum of 1 – 2 years of experience within Regulatory and Medical Devices/IVDR/MDR skills and CRO or Medical Devices or BioTech industry side.

Regulatory Affairs Executive – apply here

Regulatory Affairs Executive job openings in Hyderabad
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