Junior Regulatory Affairs Specialist
at Zentiva Group as
București, Municipiul București, Romania -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 18 Dec, 2024 | Not Specified | 20 Sep, 2024 | N/A | Good communication skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Your responsibilities:
- To compile and prepare the registration documentation according to current guidelines with the aim to obtain marketing authorisation, variations approval, renewals, to implement DRA requirements into internal company standards.
- To compile, check, update and audit registration documentation according to legislative requirements, to keep documentation to finished products.
- To cooperate with the relevant departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings.
- To monitor the legislation and the development trends in the branch for the purpose of implementation of DRA requirements into internal company standards.
- Independent preparation of documentation for complex registration procedures. Evaluation of the course of registration procedures.
- The active cooperation on the development/licence projects for the purpose of registration documentation preparation based on standard requirements of DRA.
We require:
- University degree in chemistry/natural science/pharmacy.
- Experience in Regulatory Affairs welcome
- Knowledge of the European DRA legislation.
- Strong communication and organizational skills, presentation skills.
- Advanced knowledge of English
Responsibilities:
- To compile and prepare the registration documentation according to current guidelines with the aim to obtain marketing authorisation, variations approval, renewals, to implement DRA requirements into internal company standards.
- To compile, check, update and audit registration documentation according to legislative requirements, to keep documentation to finished products.
- To cooperate with the relevant departments, to set partial tasks and check their realization for the purpose of controlling all the processes of registration proceedings.
- To monitor the legislation and the development trends in the branch for the purpose of implementation of DRA requirements into internal company standards.
- Independent preparation of documentation for complex registration procedures. Evaluation of the course of registration procedures.
- The active cooperation on the development/licence projects for the purpose of registration documentation preparation based on standard requirements of DRA
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
București, Romania