We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Specialist/Assistant Manager - Regulatory Affairs
- Provide input and advice to project teams on eCTD requirements and submission-readiness
- Perform technical quality control (electronic functionality, adherence to required standards) of dossier documents
- Check all the submission related documents from eCTD technical point of view to comply to the Health Authority requirements as well as client’s expectations
- Supporting the client in aligning the process maps/SOPs/WI as per any updates
- Provide input and advice to project teams on “submission readiness” requirements for document components
- Qualification: Bachelor/ Master of Science/ Pharmacy
- Experience: 6+ years of Regulatory Operations
- Skills: Hands on experience in publishing, mentoring, troubleshooting, performing QC checks
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms Aditi Panchal
Senior Specialist - Human Resources
Agencies only by prior agreement for the specific job opportunity.