Compensation: Best in the industry
Education: UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,B.Tech/B.E. - Any Specialization PG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Role: Regulatory Affairs Mgr
Functional Area: Engineering Design, R&D
Posted Date: 15 Jul
Desired Candidate Profile
Candidate should be B.Tech/ B. Pharm/ B. Sc (depending on exp)
Job Description
1) Handle e-submission activity related to Compilation and generation of XML for regulatory documents with the help of eCTD Xpress publishing tool
2) Perform a wide variety of work in preparation of e-submission documents as book marking & hyper linking of the documents. Preparation of folder hierarchy in the Documentum/ File share, Preparation of document tracking sheet.
3) To ensure all Quality dossier submission as per ICH/regional requirements
4) Acts as IT interface between Regulatory & IT team at company- Lifecycle management for submitting query responses to the agency.
Keywords: Regulatory affairs
Our client is MNC, posses strong brand equity in the market