Regulatory affairs Officer / Executive Vacancies Gurgaon

urgent vacancy for regulatory affiairs coral drugs gurgaon6050398722519049192

urgent vacancy for Regulatory Affiairs in our company @ Coral Drugs Pvt. Ltd-API (Gurgaon/ Sonipat).

Job Description: –

Regulatory affairs jobs – Coral drugs

Designation : Officer / Executive – RA

  • Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.
  • Submission of technical data package and Applicant’s Part for semi-regulated markets
  • Submission of response to deficiencies received from authorities and customers
  • Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets
  • Use of eCTD software’s and submission gateways like ESG & CESP
  • Providing regulatory inputs in early development phase of APIs
  • Review of change controls and technical data required for DMF submissions
  • Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF
  • Preparation of LoA and commitment and data management
  • Submission of change notification for customer.
  • Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps
  • Maintenance of database for regulatory submissions including customer notifications · Well versed with current regulatory guidelines.

Application Process : Interested can share our CV @ hrcdpl-3@coraldrugs.com

urgent vacancy for regulatory affiairs coral drugs gurgaon6050398722519049192
Regulatory affairs Officer / Executive Vacancies Gurgaon

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