- Job Title: API Regulatory Affairs Executive/Officer
- Company: MSN Group
- Degree: M.Sc. (Chemistry), M. Pharma, B. Pharma, or equivalent
- Location: Hyderabad/Secunderabad ( Pashamailaram)
- Experience: 1–8 years (Freshers with relevant qualifications can apply)
- Employment Type: Full-Time (Walk-in Drive)
- Salary: 5L – 8L year
Walk in Drive API Regulatory Affairs Dept at MSN Grp, Are you a professional professional in API Regulatory Affairs or looking to begin a promising profession in this dynamic vicinity? Join us for our Walk-in Drive organized with the aid of MSN Group, a main name inside the pharmaceutical enterprise, wherein innovation and awesome move hand-in-hand. This is a super possibility for enthusiastic and gifted humans to be a part of a growing organization and make a contribution to the achievement of its regulatory functions.
About MSN Group
MSN Group is a globally recognized pharmaceutical business employer with a strong focus on Active Pharmaceutical Ingredients (APIs), formulations, and modern-day studies. Known for our unwavering willpower to super and compliance, we have been given a corporation presence in domestic and global markets. Our modern-day production facilities and R&D facilities perform in compliance with worldwide requirements which encompass USFDA, EMA, and WHO-GMP.
Our Regulatory Affairs Department performs a critical feature in making sure our products meet international regulatory necessities, gaining approvals for product registration, and keeping the very exceptional wonderful requirements throughout markets international.
Job Responsibilities
Candidates becoming a member of the API Regulatory Affairs Department might be liable for the following:
- Dossier Preparation & Submission:
- Compile, compare, and position up Drug Master Files (DMFs), CTD/eCTD dossiers, and different regulatory files for several markets that embody USFDA, EU, TGA, Health Canada, and ROW.
- Ensure well-timed responses to regulatory queries and deficiencies.
- Regulatory Compliance:
- Maintain compliance with regulatory necessities for APIs in the path of their lifecycle.
- Stay up to date with worldwide policies and provide inputs for inner gadget enhancements.
- Coordination and Documentation:
- Collaborate carefully with R&D, QC/QA, and production teams for important facts compilation.
- Review manufacturing, analytical, and balance statistics to ensure alignment with regulatory expectancies.
- Audits and Inspections:
- Support regulatory inspections and audits with the useful resource of presenting correct documentation and clarifications.
- Work on CAPAs (Corrective and Preventive Actions) publish-audits to beautify compliance.
Who Should Attend?
We are searching out applicants with:
- Education: M.Sc. (Chemistry), M. Pharma, B. Pharma, or identical qualifications.
- Experience: 1–8 years in API Regulatory Affairs within the pharmaceutical company.
- Key Skills:
- Strong know-how of global hints (ICH, USFDA, EMA, and plenty of others.).
- Hands-on experience in dossier compilation, submissions, and handling regulatory queries.
- Proficiency in CTD/eCTD format documentation.
- API Regulatory Freshers with a keen interest in regulatory affairs and relevant educational facts are also encouraged to attend.
Why Join MSN Group?
- Opportunity to paint with an industry leader in API manufacturing.
- Competitive reimbursement and increase-oriented profession paths.
- Exposure to worldwide markets and regulatory practices.
- State-of-the-art work centers with dynamic and collaborative painting surroundings.
- Training programs and mentorship from organization specialists.’
- Cargill Recruitment Work From Home
- OLX Hiring Digital Media Sales- Account Manager
- Vinyl Graphics Technician job at Stratus