46 Job openings found

1 Opening(s)
2.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 5.00 LPA
Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...
1 Opening(s)
10.0 Year(s) To 25.0 Year(s)
30.00 LPA TO 35.00 LPA
Experience: 10+ years of experience including team handling experience in similar domain Location: Ahmedabad, Gujarat   Summary of Profile specifications:   Incumbent should have sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations.  He/she should be a seasoned professional with leadership qualities, have knowledge about NDCT rules, Biosimilar guidelines, cGMP ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 4.00 LPA
Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
12.0 Year(s) To 15.0 Year(s)
Not Disclosed by Recruiter
Ensure regulatory compliance data execution for the Region.• Ensure regulatory compliance and effective communication to all stakeholders (e.g. PS (Product Stewardship) Region Heads and teams, any other PS department, Business Unit interfaces, Procurement etc.)• Align team goals with PS (Product Stewardship) global targets while adhering to Clariant values.• Drive continuous ...
6 Opening(s)
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...
1 Opening(s)
0 To 5.0 Year(s)
3.00 LPA TO 3.00 LPA
The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information sought etc. Such regulatory offices include DGCA, Various Ministries, AAI etc. The official under the role w The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information ...

Drop Your CV

We will consider your Profile for future Jobs

Submit Profile