Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

Senior Research Associate at AVEVA DRUG DELIVERY SYSTEMS INC

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

05 Apr, 26

Salary

0.0

Posted On

05 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Dossier Compilation, Technical Document Review, Controlled Correspondences, Query Responses, Cross Functional Communication, Document Change Controls, Regulatory Files Maintenance, Training, USFDA Updates, Bio Related Documents, Specifications, Protocols, BMRs, BPRs, ANDA Compilation

Industry

Pharmaceutical Manufacturing

Description

Job Details Job Location: Prashanti Nagar IE Kukatpally Hyderabad, Telangana 500072 Job Shift: Day Prepare submission check-list based on regulatory & product specific requirements Dossier compilation and review of ANDA’s for different dosage forms. Review of all technical documents which are required for ANDA compilation (Specifications, STP, COA’s, protocols, BMR’s, BPR’s, Bio related documents etc....) Review of documents (Master BMR’s, Master BPR’s, specifications, protocols, EIR report, IIG etc...) received from other cross functional teams for the products under development. Preparation and review of controlled correspondences for different dosage forms as per the R&D request. Compilation of sections required for query responses received from Agency. Communicating with the cross functional teams and CMO’s for requesting the documents required for ANDA compilation. Compilation of post approval submissions (CBE-30, PAS) if applicable Checking for the current version of documents for submitting it to Row market as per requirement Preparation of checklists (to review the BMR, BPR, ANDA document request, ANDA checklist for internal references). Checking for USFDA current updates and new Guidance’s published in website. Training to fresher in the department with all Regulatory Affairs aspects. Reviews document change controls. Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation. Following with USFDA and EMA sites for current updates. Any other related duties as assigned by Team Leader M.Pharmacy B.Pharmacy/M.pharmacy with experience of 4 to 8 years in Formulation Regulatory Affairs.

Responsibilities

The Senior Research Associate will prepare submission check-lists and compile dossiers for ANDA submissions, reviewing all necessary technical documents. They will also communicate with cross-functional teams and maintain regulatory files.