Job Description
1) Works effectively within a team environment but may work independently delivering services within their area of competence 2) Must be able to work independently on submissions, mentor publishers and proactively takes up publishing and related activities 3) Understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices. 4) Responsible for compiling, publishing and QC of regulatory submissions 5) Has previous experience of publishing high quality submissions in eCTD, NeeS and pCTD formats 6) Understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices. 7) Management of predominantly EU regulatory operations publishing work - including: . Mailbox & tracker management . Schedule & timelines management between client and Parexel teams . Final 20% QC of published dossiers . Dispatch via CESP/agency portals Archival via client RIM systemQualifications B.Pharmacy, M.Pharmacy or any life science related discipline
💡 Quick Summary
Seeking a career-building opportunity? The Senior Regulatory Affairs Associate position is now open for candidates interested in the Remote Jobs sector. This role in Bangalore offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Remote Jobs is a plus.