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)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Candidate having experience of Dossier Compilation, Liasioning with Regulatory consultant.
Collect and compiled documents from each and every department and submit to client.
Regulatory assistance to client.
Preferable experience in ROW, Middle East and Latin America Market.
Office time: 9:00 AM to 5:30 PM
Job location -Mehsana
for further details call ...
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 ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Keep in touch with international legislation, guidelines and customer practices
Keep up to the date with a company’s product range
Ensure that a company’s products comply with the current regulations.
Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
1. Well acquainted with latest ISO 13485:2016 , CE & CDSCO norms forMedical Devices all class ( Preferably cardiac)2. Having experience of preparing dossiers for varieties of countries andtheir rules and regulations.3. Must have experience of handling ISO , CE & CDSCO audits.4. Experience of ...