Company Overview
MSN Group is one of the fastest-growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished Dosages in India. Established in 2003, MSN Group operates eight API manufacturing plants (including one dedicated to Oncology), two finished dosage facilities, with an additional facility for Oncology under construction. We have a dedicated R&D center and are expanding rapidly at a rate of 30-40% annually. Our facilities are ISO 9001-2000 certified and approved by WHO: GMP, EU: GMP, and USFDA.
Walk-In Drive Details for API Regulatory Affairs Department (RA)
Position: Executive / Senior Executive / Junior Manager – API Regulatory Affairs
Department: API Regulatory Affairs (API RA)
Qualification: M.Sc
Experience: 2 to 8 years in regulatory affairs within the pharmaceutical industry
Work Location: MSN R&D Center, Pashamylaram, Isnapur, Telangana
Interview Details
- Date: 13-09-2024
- Time: 9 AM to 2 PM
- Venue: MSN Laboratories Pvt. Ltd., MSN R&D Center, Pashamylaram, Isnapur, Patancheru, Sangareddy
- Contact: 040-30438786
Key Responsibilities
- Regulatory Submissions:
Prepare, submit, and manage regulatory filings for API products. This includes new drug applications, amendments, and variations, ensuring compliance with relevant guidelines and regulations. - Documentation Management:
Maintain, review, and update regulatory documentation such as drug master files (DMFs) and technical files to support product registrations and renewals. - Compliance Assurance:
Stay informed about regulatory changes, assess their impact, and provide recommendations to ensure ongoing compliance. - Communication:
Interact with regulatory authorities, addressing inquiries, handling requests, and managing inspections and audits. - Cross-functional Collaboration:
Work with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance for API-related activities. - Quality Standards:
Ensure that API products meet GMP and other relevant quality regulations, maintaining high standards for product safety and quality. - Regulatory Strategy:
Contribute to the development of regulatory strategies for product development and lifecycle management.
Job Description Summary
| Position | Executive / Senior Executive / Junior Manager |
|---|---|
| Qualification | M.Sc |
| Experience | 2 to 8 years in API Regulatory Affairs |
| Location | MSN R&D Center, Pashamylaram, Isnapur |
| Department | API Regulatory Affairs (API RA) |
Interested candidates can send their CVs to:
- dinesh.baratam@msnlabs.com
- deepika.nakka@msnlabs.com
