!! Urgent Requirement !!
Position Name: MANAGER (DRA)
Department: Drug Regulatory Affairs (DRA)
Company Name: Aishwarya Healthcare
Job Location: Zirakpur (Chandigarh).
Profile Overview:
Manager (Principal Scientist) –DRA, Responsible for Preparation of monthly Dossier planning after coordination with marketing team. Dossier planning approval with Director. Sending monthly planning to all members of the DRA Department. Regularly update with current country guidelines and circulate to all members of DRA. Query handling for all the territories. Coordinate with the marketing team for any additional documents like Import permit for sample purpose.
Roles and Responsibilities:
Regularly coordinated with QA, QC, and Production department regarding new sample plan for trial, new documents requirement from QC and QA Department. Update to QA, QC, and Production department with current guidelines like storage condition, Presentation of documents, etc. Coordinate with the Artwork department for the Preparation of artwork with current storage requirements. Review of artwork for export purposes.
Attributes and Skills required for the position.
· Working knowledge of SAP system.
· Working in Excel & PowerPoint.
· Minimum 10 years of experience in DRA preferably from Pharma Industry.
Educational Qualifications:
B. Pharma, M-Pharma/ M.Sc. Candidate will be preferred.
Interested candidates may send their updated cv at