Ind-Swift Hiring Regulatory Affairs Officer/Executives Wanted

Ind-Swift Hiring Regulatory Affairs Officer/Executives – Elevate Your Career Today

Ind-Swift Ltd, a global leader in API manufacturing, boasts 6+ regulated manufacturing sites across Punjab and Jammu. We cater to the API needs of regulated markets, including USFDA, EDQM, PMDA, ANVISA, EU-GMP, KFDA, NMO, ANSM, Cofepris, TGA, WHO, and ROW. At Ind-Swift Laboratories Ltd., we are excited to announce opportunities in the Regulatory Affairs Department.

Company Vacancies List

Join our team as a Regulatory Affairs Officer/Executive at our OSD Formulation Site in Derabassi. Explore the open positions:

1. Regulatory Affairs Officer/Executive
   • Qualification: B.Pharm / M.Pharm
   • Experience: 4 to 8 years
   • Location: Panchkula & Gurugram
   • Position Title: Regulatory Affairs Officer/Executive
   • Company Name: Ind-Swift Ltd
   • Salary: Competitive (Commensurate with experience)

Job Description

Join a dynamic team and contribute to the success of Ind-Swift Ltd. Here’s what the Regulatory Affairs role entails:

About the Department & Responsibilities

In the Regulatory Affairs department, your responsibilities will include:

1. Preparation and review of registration dossiers as per CTD/ACTD and country-specific formats for RoW, Europe, and the US Market.
2. Compilation of responses to queries received from regulatory authorities/clients.
3. Compilation of Variation and Re-registration documents as per the required checklist.
4. Review of quality documents such as API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation, and Stability, ensuring compliance with guidelines.
5. Coordination with various departments like QA, QC, and Production to project the document requirements for appropriate submissions.
6. Compilation of documents to bid international tenders for ROW markets.
7. Preparation and review of SPC, Product monograph, package insert, and labeling.

How to Apply

If you are passionate about regulatory affairs and eager to contribute to our success, we invite you to apply. Send your CV to hr.gbu@indswiftlabs.com or WhatsApp us at +91-7087978441.