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Regulatory Affairs Associate @ SMS Pharmaceuticals

Home > Quality (QA-QC)

 Regulatory Affairs Associate

Job Description

Require 2 Candidates 3 to 5 years experience

Job description:

  1. Understanding of US market, Europe and Canada regulatory guidelines and requirements
  2. CTD modules preparation for US market, Europe and Canada
  3. Post-approval submission for US and Europe and emerging markets
  4. Emerging markets/ROW countries regulatory requirements knowledge
  5. Review of technical documents from various function (QA QC And FRD and ARD)
  6. ECTD/ publishing experience

Require 2 Candidate 1.5 to 2.5 years experience

Job Description

  1. Any other department experience (QA documentation, Ard or FRD, QC)
  2. Dossiers submissions in CTD & ACTD formats for Rest of the world (RoW) Countries
  3. Review of technical documents

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Quality (QA-QC)
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs Associate

Contact Details:

Company: SMS Pharmaceuticals
Location(s): Hyderabad

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₹ 1.5 - 4.0 Lakh/Yr

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SMS Pharmaceuticals

\r\nThe company is a reputed whole trader and importer of Pharma and cosmetic excipients and is in the sales of excipients all  over India