MSN Laboratories Pvt. Ltd (MSN Group) is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India. Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified, WHO: GMP, EU:GMP and USFDA approved. Our manufacturing units are designed to confirm to the principles of Quality, Safety and sound Environment.
Date and Time:
Walkin Interview on 6th July from 9.30 AM – 5.30 PM onwards
Venue Details : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy
- qualification: M.Sc
- Experience : 02-07+years
- Department: API Regulatory Affairs Dept – ( API RA )
- Designation:Executive / Senior Executive / Junior Manager
- Job Location: Hyderabad/Secunderabad ( Pashamailaram)
- Openings: 01
Job description:
Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 2-7 years of regulatory affairs experience in the pharmaceutical industry.
Key Responsibilities:
Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations.
Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals.
Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance.
Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required.
Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities.
Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations.
Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management.
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