Regulatory Affairs Executive - EU

Emcure Pharmaceuticals Limited; Sanand; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Emcure Pharmaceuticals Limited is seeking an Executive/Officer for Regulatory Affairs - EU/UK. The role requires M.Pharm and 3–8 years of experience in regulatory markets, with hands-on in EU/UK submissions and health authority interactions.

The candidate should be proficient in eCTD documentation, respond to agency queries, and handle initial marketing authorization applications as needed. Prior experience with module 1-5 submissions is essential.

Qualifications

• Must have Regulatory Market experience in EU and UK.
• Must have worked and supported authoring of module 1-5.
• Should have good experience of post-approval variations and Initial MA applications.
• Should have worked on health agency queries and be aware of documents like eCTD and ICH guidelines.

Skills

EU/UK regulatory experience

Module 1-5 submissions

Post-approval variations

eCTD awareness

ICH guidelines knowledge

Education

M.Pharm

Job description

Department: Regulatory Affairs - EU / UK

Designation: Executive / Officer

Qualification: M.Pharm

Experience: 03 to 08 years

Job Details mentioned below:

• Must have Regulatory Market experience like EU and UK countries.
• Must have worked and support authoring module 1-5.
• Should have good experience of post approval variation Initial marketing authorizing application experience is add on.
• Should have worked on health agency query, awareness of docs like eCTD, ICH guidelines.