pharmalex_job_career



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.

 

Specialist - Regulatory Affairs

Your Profile

  • Responsible for managing all aspects related to the preparation, tracking, compilation, publishing, and technical quality control of all assigned maintenance regulatory submissions  
  • Document level publishing like OCR PDF file, create bookmark, Hyperlink, Edit Documents, extract picture and text from pdf and export to word file according to the ICH guidelines 
  • Create, compile, and validate eCTD and other submissions including (A)NDAs, MAAs, Variations, Renewals, Response to queries etc. 
  • Trained on the required various software tools 
  • Ensure all the submission dispatched related Acknowledgements received on portal from agencies and their archival in organized path for future reference 
  • Update eCTD publishing tracking sheet on regular basis.
Requirements
  • Qualification: Bachelor/ Master of Science/ Pharmacy 
  • Experience: 2 - 4 years of Document publishing experience 
  • Skills: Create, compile and validate eCTD and NeeS including MAAs, amendments, variations, renewals, etc. 
  • Expert in HA submission publishing requirements globally 
  • Knowledge, of Regulatory processes and related tools (document management, publishing, etc.) 



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.