Consultant
Search Jobs
Search by job, company or skills
Search by job, company or skills
JOB DESCRIPTION
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.
RESPONSIBILITIES:
• Strong understanding of eCTD, NeeS, and ICH guidelines.
• Familiarity with Regulatory systems and Publishing tools.
• Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
• Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
• Manage lifecycle submissions including variations, amendments, and renewals.
• Perform document-level publishing, hyperlinking, bookmarking, and validation.
• Conduct quality control checks to ensure submission readiness.
• Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
• Stay updated with global regulatory guidelines (ICH, FDA, EMA).
• Detail-oriented with a collaborative mindset.
Job ID: 153727837
Skills:
Power Bi, Advanced Excel, Spi, Forecasting, EAC, Cost management, EVM concepts, Scheduling, Reporting, Primavera P6, MS Project, cpi
Skills:
Business analyst functional roles, Ability to review AI outputs for quality and reliability, Tax technology digital automation initiatives, Clear written and verbal communication, Exposure to tax research tools document analyzers or workflow platforms, Exposure to Generative AI, Working understanding of tax concepts documents and processes, Strong analytical business analyst mindset, AI based tools usage limitations risks, High attention to accuracy and professional defensibility, Ability to structure requirements workflows and problem statements, AI enabled or workflow based solutions within tax teams, Strong proficiency in MS Excel, Tax assignments
Skills:
Ms Excel, Internal Controls, Compliance regulations, KYC and identity verification processes
Skills:
data centers , business model transformation , business case design , API security, Advanced Excel, Tableau, JIRA, Iot, Confluence, Power Bi, Agile Methodologies, Cybersecurity, Rally, product innovation, SD WAN, SASE, FWA, Sales acceleration, Edge Computing, Ai, Competitive Benchmarking, Private 5G, MS Projects, 5G, Telecom Industry Expertise, Opportunity sizing, market assessments
Skills:
Veeva QMS, Technology, Life Sciences, Cloud based Regulatory Systems
