Ind-Swift Ltd Hiring for Regulatory Affairs-Call or Mail On HR

Ind-Swift Ltd Walk-in Interview 2024.Ind-Swift Ltd Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue..

Vacancy details:

• Department : Regulatory Affairs
• Qualification: B Pharma/M Pharma with 3-5 years of experience of Regulatory Markets (EU/MHRA/USFDA)
• Experienced: 3-5 years

Important Details :

• Location : R&D Centre Panchkula
• Post of date:27/12/2024
• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to Face
• Interview Rounds of Interview: HR

Job Description: Greeting from Ind-Swift Ltd  !!!!

Responsibilities

1. Preparation and review of registration dossiers as per CTD/ACTD and country specific formats.

2. Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance.

3. Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.

4. Co-ordination with clients for the tracking and status update of project plans.

5. Preparation of response to queries raised by regulatory authorities as well as by clients.

6. Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders.

7. Literature search/survey to compile clinical and non-clinical part within registration dossiers.

8. Preparation and review of SPC, Product monograph, package insert and labeling information.

9. Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC.

10. Involved in preparation of renewal application for certificates like GMP, CPP, WHO-GMP, GLP & Non-Conviction Certificate.

 

 

SEND YOUR RESUME

Email: hr.gbu@indswiftlabs.com

Call: 7087978441