Ind-Swift Limited is a leading pharmaceutical company with a strong global presence, specializing in the development and manufacturing of high-quality formulations. With a focus on innovation and compliance, Ind-Swift’s Global Business Unit (GBU) is known for its expertise in regulated markets like the EU, USFDA, and MHRA. The company fosters a dynamic work environment, encouraging professional growth and excellence in regulatory affairs.
Job Description: Regulatory Affairs (OSD Formulations)
We are seeking experienced Regulatory Affairs professionals with expertise in Oral Solid Dosage (OSD) formulations for regulated markets. If you have a strong background in dossier submissions, compliance, and regulatory strategy, this is an excellent opportunity to join a growing team.
Key Responsibilities:
- Dossier Preparation & Review: Compile and review registration dossiers in CTD/ACTD and country-specific formats.
- Quality Documentation: Review API DMFs, product specifications, BMR/BPR, process validation, and stability reports for compliance.
- Cross-functional Coordination: Work with QA, QC, and Production teams to gather necessary submission documents.
- Client & Regulatory Communication: Track project status, respond to regulatory queries, and prepare MAF, Product Questionnaires, and tender documents.
- Literature Research: Conduct clinical/non-clinical research to support dossier submissions.
- Labeling & Compliance: Prepare SPC, product monographs, packaging inserts, and labeling as per guidelines.
- Regulatory Approvals: Handle applications for Product Approvals, CPP, GMP renewals, WHO-GMP, and FSC.
Desired Skills & Experience:
- 3-5 years in Regulatory Affairs (OSD Formulations)
- Strong knowledge of EU, USFDA, MHRA guidelines
- Expertise in CTD/ACTD dossier preparation
- Excellent communication & project management skills
How to Apply?
Interested candidates can send their updated CV to hr.gbu@indswiftlabs.com with the subject line: “Application for Regulatory Affairs – OSD Formulations”.
Join Ind-Swift Limited and be a part of a team shaping the future of pharmaceuticals!
