tyle="text-align: center;">Life Sciences MakroCare Job – Associate Regulatory Affairs Vacancy Available
Life Sciences MakroCare Job – Associate Regulatory Affairs Vacancy Available. BSc & MSc life science degree can apply for an Associate Regulatory Affairs position at Makrocare. Interested candidates must check the details below first and apply online.
Job Id: 18112022
Title: Associate Regulatory Affairs
Job Type: Permanent
City: Hyderabad – Madhapur
State: Telangana
Job Description: Jr Regulatory Affairs Executive
- Preparation, Review and submission of Technical documents (CTD/ACTD) for Devices of Regulatory and Non Regulatory Markets.
- 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, 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 & Medical Devices/IVDR/MDR skills and CRO or Medical Devices or Biopharma industry side.
Qualification: Any UG/PG In Life Sciences
Experience: 1-2 Years
Job Category: Regulatory Affairs
Posted On: 11/19/2022
Expires On: 12/19/2022
About MakroCare
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology, and Medical Device industries. Their 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).
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