Loading...

Walk in Drive API Regulatory Affairs Dept at MSN Grp | Still Waiting

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...
Posted in Blog
2024-12-09
Walk in Drive API Regulatory Affairs Dept at MSN Grp | Still Waiting
  • 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.’
MORE OTHER JOBS:-
Share this article

Related Articles

Browse the latest career advices

No related articles