Executive – Regulatory Affair

Location : Goregaon, Mumbai
Experience : 4+ years.
Education : B.Sc/B.Pharm/M.Sc/M.Pharm
Job Description

  • Coordinating with manufacturing unit for the documents required for registration process and replying queries reply.
  • Preparing dossier for registration & Re-registration for exporting countries as per respective countries guideline and handling queries related to registration.
  • Coordinating with artwork department for the development of artwork as per countries requirement.
  • Checking outer carton Sticker label for export order for some countries i.e. Algeria, Jordan , Iraq etc.
  • Arranging and sending samples required for registration purpose.
  • Legalization from Embassy, Attestation from Chambers of documents for registration purpose as per countries requirement.
  • Sending packing instruction to factory for export order and handling queries related to it, if any. For new party or country getting confirmation from party for packing instruction.
  • Arranging for the documents required for local tender purpose.
  • Identifying products for both local & export tender.
  • Registration with Government institute like CPC & CSD – Coordinating with plant and consultant to arrange for the documents required for registration .
  • Arrange for the documents for registration and handling queries for applying License with CDSCO.
  • Free Sale Certificate – arranging documents for applying FSC.
  • Maintaining renewal of Quality certificate (i.e. ISO 9001, ISO 13485 , CE Certificate, USFDA Certificate, Export house, License, Pollution Control Certificate, Non -Conviction Certificate, Manufacturing & Marketing Certificate etc.)
  • Quality Certificate Audit – Coordinating with plant and auditing agency to arrange for required documents for audit purpose and scheduling the audit and also ensuring that all the NC are closed on given timeline.
  • Registration with GS1 India for new Barcode and maintaining the renewal of the same.
  • Excellent Communication and negotiation skills
  • Good in excel software.
  • Reporting to Managing Director.

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