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Regulatory Affairs at MSN Labs
Overview
Position Name: Regulatory Affairs
Organization: MSN Labs
Qualification: M.Sc
Experience: 2 to 8 Years
Salary: N/A
Location: Pashamylaram
About Us: 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.
About MSN Labs
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.
Job Role: Regulatory Affairs
As a member of the API Regulatory Affairs Department at MSN Labs, you will be responsible for preparing, submitting, and managing regulatory filings for API products. This role requires attention to detail, a good understanding of regulatory guidelines, and the ability to work collaboratively with various teams.
Key Responsibilities
- Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations.
- Maintain, review, and update regulatory documentation such as drug master files (DMFs) and technical files.
- Stay informed about regulatory changes and provide recommendations to ensure ongoing compliance.
- Interact with regulatory authorities, addressing inquiries, handling requests, and managing inspections and audits.
- Collaborate with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance.
- Ensure that API products meet GMP and other relevant quality regulations.
- Contribute to the development of regulatory strategies for product development and lifecycle management.
Qualifications
- M.Sc
- 2 to 8 years of experience in regulatory affairs within the pharmaceutical industry
Location Details
Job Location: MSN R&D Center, Pashamylaram, Isnapur, Telangana
How to Apply
Interested candidates can send their CVs to:
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
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