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.

    Tell us your name

    Fill out your details

    Enter your Address

    How did you hear about this job vacancy?

    When are you available to start the job?

    Upload Resume / CV