Regulatory Publishing Expert

Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD 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 eCTD submissions, including...

Job Title:Regulatory Affairs Manager - Submission PublishingJob Description:We are seeking a proactive leader to head our Submission Publishing team. This individual will be responsible for delivering high-quality regulatory submissions while ensuring compliance with global health authority requirements.This role involves managing a high-performing team,...

Regulatory Affairs Manager - Submission PublishingThe role involves leading a high-performing team responsible for delivering regulatory submissions in compliance with global health authority requirements.Key responsibilities include managing workload vs. resource allocation, overseeing the publishing workflow, conducting regular performance evaluations and...

Role Description This is a full-time, on-site role based in Mumbai for a Desktop Publishing Operator. The Desktop Publishing Operator will be responsible for tasks such as desktop publishing, typing, printing, graphics design, and pre-press operations. The role involves creating and formatting documents for print and digital media, ensuring high-quality...

Role DescriptionThis is a full-time, on-site role based in Mumbai for a Desktop Publishing Operator. The Desktop Publishing Operator will be responsible for tasks such as desktop publishing, typing, printing, graphics design, and pre-press operations. The role involves creating and formatting documents for print and digital media, ensuring high-quality...

Role DescriptionThis is a full-time, on-site role based in Mumbai for a Desktop Publishing Operator. The Desktop Publishing Operator will be responsible for tasks such as desktop publishing, typing, printing, graphics design, and pre-press operations. The role involves creating and formatting documents for print and digital media, ensuring high-quality...

Senior Document Publishing SpecialistThe primary responsibility of this role is to serve as a single point of contact for the authoring community and subject matter expert in delivering submission-ready documents.Main ResponsibilitiesThis individual will coordinate operational aspects of document-level support activities, including collaborating closely with...

Regulatory Compliance ExpertThe Regulatory Compliance Role is a high-profile position that requires strong leadership and management skills to oversee regulatory affairs activities at the manufacturing site. The successful candidate will ensure timely regulatory submissions, compliance with regulations, and provide strategic support to business...

Document Publishing SpecialistThis is a key role in our organization, responsible for delivering high-quality submission-ready documents to support regulatory submissions. The successful candidate will have excellent document processing skills and experience in the pharmaceutical industry.Job ResponsibilitiesServe as the primary point of contact for the...

Job Title: Regulatory Compliance ExpertWe are seeking an experienced Regulatory Compliance Expert to join our team. The ideal candidate will have a strong background in compliance, regulatory affairs, and risk management.Key Responsibilities:To ensure adherence to all applicable RBI and IRDA guidelines, circulars, and Master Directions related to...