Regulatory Affairs Specialist- Labelling

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.

Location- Noida / Mumbai


Regulatory Affairs Specialist- Labelling

Your Job

• Handling of CCDS related documents (Core documents (for SPC/PIL), Justification documents, change history, local deviation forms etc.)
• Archiving (relevant communication/documents)
• Handling of labelling documents in DMSs
• Drafting comparisons of CCDS vs. Local labeling
• Labelling background preferred, IT affinity, very detail oriented (understanding for minor text details), excellent communication skills

Your Profile

• Experience: Minimum 3 years in Regulatory Affairs Labelling
  Market exposure required : US/Europe
   

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.