Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Apotex
Designation : Assistant Manager
Function : Regulatory Affairs
Functional Area : Injectables
Job Role Summary : Compilation and Review of New Product Applications, Product Life Cycle Management (PLCM) submisisons, eCTD compilation and addressing deficiencies of Injectables for various markets like US and Canada
Job Profile :
  • Review and compilation of Sections/Modules for new product submissions i.e., ANDAs, NDAs and ANDS
    Addressing deficiencies received for new product submissions of Co-development projects (Injectables/Sterile drug products).
  • Review of all technical documents required for compiling the post approval submissions (PAS, CBE-30, CBE and sANDS) and query responses.
  • Review and finalization of Sterility Assurance Package for Injectables/Sterile drug products
  • Review/assessment of change controls which are received from CROs/CMOs
  • Review of Drug Master Files/Active master Files/CEPs in relation to New Product Submissions/ Post Approval Submissions
  • Relevant communication and follow ups with the respective customers/stake holder required for compilation, submission and respective query responses.
  • Responsible for eCTD/RIMS activities of co-development submission
Job Requirements :
  • Knowledge, Skills and AbilitiesSound understanding regulatory affairs submissions.
  • Steriltiy Assurance Package for Injectables
  • Expertise in product life cycle management.
Work / Job Experience : 8-10 Years
Type of Experience : Pharma Regulatory experience
Academic Qualifications :
  • 8 to 10 years of experience in Regulatory Affairs activities which muct include 3 to 4 years of experience in team/people management

Website LinkedIn Apotex

To apply for this job please visit careers.apotex.com.