Executive – Regulatory Affair
Location : Goregaon, Mumbai
Experience : 4+ years.
Education : B.Sc/B.Pharm/M.Sc/M.Pharm
- 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.