Bla regulatory publishing specialist – veeva ectd

Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in e CTD format using Veeva Vault e CTD Publishing.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of e CTD submissions, including file structure, hyperlinks, and metadata.Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.Track submission timelines and deliverables to meet regulatory deadlines.Required Skills & Qualifications:Strong experience in Veeva Vault e CTD Publishing for BLA submissions.Knowledge of global regulatory requirements (FDA, EMA).Hands-on experience in preparing e CTD sequences and publishing ready dossiers.Attention to detail with strong organizational skills.Good communication skills to collaborate with multiple stakeholders.Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.