Assistant Manager – Regulatory Affairs (ROW Market)

From 7 to 10 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

  • To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa , Mexico and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
  • To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
  • To review of documents for adequacy and accuracy.
  • To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
  • To arrange the samples as per country requirements.

Role:Regulatory Affairs Compliance

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Legal & Regulatory

Role Category:Corporate Affairs

Employment Type:Full Time, Permanent

Key Skills
Skills highlighted with ‘‘ are preferred keyskills


PG:M.Pharma in Any Specialization

Company Profile

Alkem Laboratories

Alkem Laboratories Ltd

Company Info
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Contact Company:Alkem Laboratories

Address:Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208