pharma regulatory affairs jobs – Indi Swift Laboratories

OPEN POSITIONS for Formulation Site Drug Regulatory Affairs Executive / Officer / Sr. Officer

Required Education : B Pharmacy / M Pharma
Experience : 3-5 years of experience

Location: Panchkula (3) & Gurugram (3)

Responsibilities

  • Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance.
  • Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.
  • Co-ordination with clients for the tracking and status update of project plans.
  • Preparation of response to queries raised by regulatory authorities as well as by clients.
  • Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders
  • Literature search/survey to compile clinical and non-clinical part within registration dossiers.
  • Preparation and review of SPC, Product monograph, package insert and labeling information.
  • Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC
  • Involved in preparation of renewal application for certificates like GMP, CPP, WHO-GMP, GLP & Non Conviction Certificate.

Note: Only MHRA, EU GMP & ROW exposure candidates will be entertained.

Contact Number : 70879 78441
Contact Mail : hr.gbu@indswiftlabs.com

Address : Ind-Swift Ltd., Off. NH-21, Vill. Jawaharpur, Derabassi, Distt. Mohali, Punjab -140507

pharma regulatory affairs jobs
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