torrent PHARMA
We are HIRING! Join Our Team
Department ;Regulatory Affairs
POSITION : Assistant Manager/Executive
QUALIFICATION:M.Pharm./ M.Sc.
EXPERIENCE:4 to 12 Years
LOCATION:Gandhinagar (Gujarat)
PROFILE & EXPOSURE :
For EU Market - Pre and Post Approval
Formulation Regulatory experience of various dosage form like Solid oral/Topicals/Solutions/Suspension/ Injectables/Ophthalmics/Peptide.
- EU dossier compilation especially for Module 1, 2 & 3
→ Seasoned experience in handling of various EU procedure like DCP, MRP, National
→National phase handling for EU procedures.
→ Post approval variation compilation and filling to various EU agencies
For US Market - Pre and Post Approval
Formulation Regulatory experience in dosage form like Solid oral/Topicals/Solutions/Suspension/Injectables /Ophthalmics/Peptide.
[ads id="ads1"]
ANDA compilation for Module 2 & 3
Query responses and Tracking of documents
PAS/CBE-30 and Annual report compilation and filling to agency
Label and SPL preparation.
Experience of eCTD compilation would be added advantage
[ads id="ads2"]
INTERESTED CANDIDATES MAY SHARE THEIR CVS ON