Snaphunt
Job description
The Offer
• Join a well known brand within Pharmaceuticals / Biotechnology
• Attractive Salary & Benefits
• Opportunity to make a positive impact
Ideal Candidate
You will be responsible for :
• Review Initial Registration, Collect and Check CPR for Post approval compliance, Special Conditions, Renewal, Final Document compilation for Variations application Prepare documentation Batch Notification Application.
• Coordinate and Check Final Artwork (NPR / commercial ) Follow-up Compliance Documents for Completion of Dossier Check the Shipment Images Compile the Valid and updated COA ( Mfr/ PTL/ Phil Local 3rd Party) Submission of the New Products and Review of PPD and MIMS as per the timeline.
• Request Payment Fees for various Payments needed (FDA/ 3rd Party Testing Lab/Procurement of RLD.
• Day-to-day work Reports should be submitted to RA Head, Doted line reporting to Country Manager and Regional RA Head.
• Working Folders and file records, Back up and maintenance.
The Profile
• You have at least 3 years post-qualification experience in a similar role.
• You have a proven track record of meeting/exceeding your targets.
• You possess excellent interpersonal as well as written and verbal communication skills.
• You have working knowledge of Two Wheeler Sales
The Employer
Our client is well established and is looking to hire a talented Regulatory Affairs Officer at their Srilanka Office.