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Regulatory Analyst

6 - 11 years

6 - 7 Lacs

Bengaluru

Posted:2 weeks ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs Documentation Veeva Pharmaceutical Regulatory Reporting CMC Drug Launch ROW

Work Mode

Remote

Job Type

Full Time

Job Description

Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool

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Lancesoft
Lancesoft
www.lancesoft.com

IT Services and IT Consulting

Herndon Virginia

5001-10000 Employees

191 Jobs

    Key People

  • Manoj Daya

    President & CEO

  • Ravi Naik

    Co-Founder & COO

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