1 Opening(s)
3.0 Year(s) To 8.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements.
Key Responsibilities
1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...
1 Opening(s)
2.0 Year(s) To 6.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Conduct Research: Perform extensive primary and secondary research using online databases, internal records, and open media to locate relevant information.
Analyze Data: Filter and interpret complex data sets, research findings, and market-related information to draw meaningful conclusions in response to client or internal queries.
Formulate Responses: Develop clear, concise, and ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
12.00 LPA TO 18.00 LPA
Job Description
Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.Manager.- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing,guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of thedepartment.- Coordination with ...
1 Opening(s)
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the ...