Oracity Life
Sciences Vacancy for Regulatory Affair
Executive
Oracity Life
Sciences was focusing on solid oral dosage forms (Tablets / capsules) with
immediate as well as modified release technology. We will be catering Granules
for immediate release, modified release tablets, different range of pellets
formulation ready to encapsulate, MUPS ready to compress along with finished
dose formulation of tablets and capsules. We have designed the facility /
systems to meet all regulatory standards (like WHO, MHRA, USFDA etc…) and will
be catering to domestic, ROW and highly regulated market.
Compiling
& Filing the Common Technical Documents (CTD) for markets like Asian
countries & ROW Market.
• Compiling
& Filing the Dossiers & Drug Master Files of country.
• Follow up
with Regulatory Affairs Department for timely submission of dossier.
• Review of
dossier received from Regulatory Affairs Department prior to MOH / Customer
submission.
Handling
technical queries received from agents and Health Authorities of respective
countries for registration of products.
• Good
knowledge about guideline like- ICH, ASEAN and ROW.
• Review and
checking of plant Specification, BMR, raw material COAs and other documents of
loan license products as per customer registered documents and sharing the same
with loan license customer as per requirements.
•
Coordination with different department for timely completion of assignments.
B.Pharm,
M.Pharm, with minimum 1 years of cumulative experience in the Regulatory Affair
department in Pharmaceutical Industry.
Location :
Butibori Nagpur
Industry Type
: Pharma/ Healthcare/ Clinical research
Functional
Area : Regulatory Affair
End Date :
5th April, 2020
Send your Resume at :-
hr@oracitylifesciences.com
Posted by Priya
Thakur
Oracity Life
Sciences
Contact
Details : 0712 - 7125174
FOR MORE JOB UPDATES
No comments:
Post a Comment