
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