Ind Swift Hiring Regulatory Affairs Officer/Executives Now

Ind Swift Limited (GBU), a renowned pharmaceutical powerhouse with a commitment to excellence. Established as a 100% EOU (OSD Formulation Site) in Derabassi, we take pride in our rich history and dedication to delivering quality pharmaceutical products. Our work culture fosters innovation, growth, and a passion for making a difference in the healthcare industry.

Company Vacancies List

Position Title: Regulatory Affairs Officer/Executives
Company Name: Ind Swift Limited (GBU)
Salary: Commensurate with experience
Company Address: Derabassi, Panchkula & Gurugram

Detailed Job Description

As a Regulatory Affairs Officer/Executive, you will be an integral part of our Regulatory Affairs department, contributing to the following:

1. Preparation and Review of Registration Dossiers: Craft and review registration dossiers in compliance with CTD/ACTD and country-specific formats for the RoW, Europe, and the US Market.
2. Response to Queries: Compile responses to queries from regulatory authorities and clients, ensuring accuracy and adherence to guidelines.
3. Variation and Re-registration Documents: Compile variation and re-registration documents as per the required checklist.
4. Review of Quality Documents: Scrutinize quality documents, including API’s DMF, finished product specifications, certificates of analysis, BMR, BPR, process validation, and stability documents for compliance with guidelines.
5. Interdepartmental Coordination: Collaborate with QA, QC, and Production departments to project document requirements for appropriate submissions.
6. International Tenders: Compile documents for bidding in international tenders for ROW markets.
7. Preparation and Review of Supporting Documents: Create and review SPC, product monographs, package inserts, and labeling information.

About the Department & Responsibilities

The Regulatory Affairs department plays a pivotal role in ensuring compliance and adherence to regulatory standards. As an Officer/Executive, your responsibilities will include dossier preparation, query response, variation and re-registration document compilation, document review, interdepartmental coordination, tender document preparation, and the creation/review of supporting documents.

How to Apply

If you are a dynamic pharmaceutical professional eager to contribute to our success story, we invite you to be a part of our team. Send your CV to hr.gbu@indswiftlabs.com or WhatsApp us at +91-7087978441.