Greetings from Aspiro!!!
We are excited to announce that we are hiring for the below positions for one of our Injectable Manufacturing facility located in Karakapatla, Hyderabad.
- Department: Regulatory Affairs
- Position: Senior Officer/Executive
- Qualification: M Pharm / B Pharm / M Sc
- Experience: 3–5 Years
Job Description:
Prepare and compile CTD/eCTD dossiers (Modules 1–5) for Injectable products.
Handle US ANDA submissions to USFDA, EU submissions to EMA, and ROW registrations.
Manage post-approval changes (PAC), variations, renewals, and supplements.
Coordinate and respond to regulatory queries / deficiency letters within timelines.
Review injectable-specific documents: Specifications, analytical method validations, sterility Assurance package, PV, stability protocols , and all dossier related documents.
Work closely with R&D, QA, QC, and Production for timely submissions.
If you are or know someone who might be good fit, please share the profile with us on careers@aspiropharma.com
Note: Please mention subject as “Regularly Affairs” .
