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Regulatory Operations Associate

2.00 to 4.00 Years   Bangalore   03 Nov, 2020
NovoTech Private Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Required Qualification(s):

  • You should be a graduate in a clinical, pharmacy or life sciences related field with at least 2 years clinical research experience gained in a pharmaceutical company or CRO.
  • Involvement in or exposure to preparation of Ethics Committee or Health Authority Applications in any country would be required. Involvement in study start up or in-house data review / monitoring and/or CRA experience would be advantageous.
  • Training on Novotech processes and local country requirements would be available to ensure your success.
  • Ensuring ICH GCP and Regulatory compliance is fundamental to the conduct of clinical research.

Core responsibilities:

  • Preparation, review and provision of ethics committee applications for clinical trials, based on the protocol, Investigator brochure and available information, to ensure timely approval of clinical trials.
  • Reviewing questions or comments raised by ethics committees, seeking further information and discussing these with the project team and/or client to formulate an appropriate response.
  • P reparation, review and provision/submission of applications to Health Authorities to ensure timely approval of clinical trials.
  • Reviewing questions or comments raised by ethics committees, seeking further information and discussing these with the project team and/or client to formulate an appropriate response.
  • Review and approval of proposed packaging and labelling for clinical trial material to ensure compliance with local regulations.
  • Preparation, review and submission of importation and/or exportation licences and/or permits for clinical trial materials, in accordance with local requirements.
  • Preparation and/or customisation and review of Patient Information Sheet / Consent form in accordance with ICH GCP and local requirements.
  • Preparation, review and approval of periodic reports to ethics committee s and Health Authorities.
  • Review, comment and approval of Activation packages for release of Investigational Product.
  • Register the clinical trial on clinical trial registries, in accordance with local regulatory requirements.
  • More experienced Associates may be assigned as a project regulatory lead for multi-region projects, taking responsibility to coordinate regulatory activities with colleagues in Asia.
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Keyskills :
clinical research experiencelife sciencesclinical trialsclinical researchclinical developmentregulatory complianceclinical trialcrocragcpichpharmaethicstrialstrainingresearchclinicalprotocolpackagingmaterials

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