Aspiro Pharma Limited is one of the leading USFDA approved pharmaceutical company with global outreach requires the following personnel for our Injectable facility, located at Karkapatla(V), Markook(M), Siddipet(Dist), Hyderabad, Telangana.
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.
Job Details:
- 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.
How to Apply:
- 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” .
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