Drug Regulatory Affair manager
Job Description:
KEY RESPONSIBILITES:
• Team Handling.
• Assist/guide team member to enable them for below: Ensure timely compilation & submission with best quality of Dossiers, (Asia, Africa, CIS and LATAM) and maintain proper records of the same.
• Handling queries for Asia, Africa, CIS and LATAM.
• Query tracker updates on weekly basis.
• Timely response / communication to overseas client - Africa, Asia, CIS and LATAM.
• If needed, also take up work of dossier compilation, variation/renewal compilation.
• Keep knowledge up to date with regards to regulatory guidelines and requirements as well as for new technical trends.
• Regulatory Development.
• Direct communication with contract manufacturer or third party manufacturer.
• Handling Queries of BD Department.
• Product Selection for new registration.
• Directly reporting to MD.
Primary Skills:
• Looking for only those having experience in core regulated & semi regulated market.
• Good communication skill.
• Good knowledge of Technical writing
Company Profile
We are a fast growing company in Pharma, Herbal Food Supplements and Cosmetics business.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.