Senior Specialist, Regulatory Affairs

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

Senior Specialist


Your Job

• Project management covering the quality, timelines, and customer satisfaction of the project.
• Create, compile, and validate eCTD and NeeS including MAAs, amendments, variations, renewals, etc. across EU/APAC/GCC/Africa regions.
• Editing of documents according to ICH guidelines (Create bookmarks and links, etc.).
• QC of published outputs published by peers and junior colleagues.
• Development of regulatory strategies for eCTD submissions
• On-site customer support, development and troubleshooting in the validation of eCTD
• Communication with regulatory authorities
• Preparation of presentations, SOPs, anWls for Internal training
• Implementation of new processes and software according to user requirements
• Training for various software tools
• Be able to provide support in CET time zone (9am-6pm CET)

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. Chhabra
Specialist, Human Resources

Agencies only by prior agreement for the specific job opportunity.