Submit The Documentation Specified Jobs

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Submit Docs Spec roles are booming as companies accelerate digital compliance and adopt AI‑powered submission tools. The shift toward cloud‑based eCTD portals and real‑time audit trails has created a surge in demand for specialists who can navigate evolving regulatory landscapes.

Positions range from Documentation Specialist and Regulatory Affairs Coordinator to Technical Writer and Compliance Analyst. Core duties include drafting and reviewing eCTD dossiers, maintaining ISO 9001 and ISO 13485 documentation in MasterControl or SharePoint, managing audit evidence, and liaising with regulatory agencies via portals such as FDA’s 21 CFR Part 11 or EMA’s portal.

Salary transparency in this niche is critical because it highlights the premium paid for expertise in GxP, data privacy, and audit readiness. Clear pay data empowers professionals to assess the true value of their certifications and seek roles that match their skill level.

Static Timing Methodology Development for Gate Level Timing Signoff

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

IBM promotes its innovative spirit and global impact through progressive thinking and technological advancements. The text highlights achievements in systems development, AI, and EDA solutions while seeking skilled professionals for challenging roles in cutting-edge hardware design.

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Company: IBM

Location: SÃO PAULO, BR

Posted Dec 09, 2025

This text promotes a Project Manager role at IBM Technology Expert Labs, emphasizing leadership in complex projects, cross-branding initiatives, and client-centric outcomes. It highlights opportunities for impactful work, collaboration with global teams, and professional growth within a high-performance ecosystem.

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Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

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Administrateur systèmes TI

Company: IBM

Location: BROMONT, CA

Posted Dec 09, 2025

IBM's Bromont facility emphasizes high-tech manufacturing, employee growth, and competitive benefits. The role involves managing IBM systems and cloud environments, with strict security and eligibility criteria for Canadian citizens.

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Company: IBM

Location: New Delhi, IN

Posted Dec 09, 2025

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Company: IBM

Location: Kolkata, IN

Posted Dec 09, 2025

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Company: IBM

Location: PETALING JAYA, MY

Posted Dec 09, 2025

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Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

The text describes a career in IBM Consulting focused on collaboration with global clients, innovation in hybrid cloud and AI solutions, and professional growth through technical expertise and cultural development. It highlights opportunities to work with cutting-edge technologies and make meaningful impacts while embracing diverse skills and experiences.

SAPコンサルタント

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

The text highlights IBM Consulting's career opportunities focusing on collaboration with global clients, innovation in hybrid cloud and AI solutions, and professional growth through strategic partnerships and technology platforms. It emphasizes curiosity, creativity, and long-term development in a supportive environment.

Werkstudent - IT Security (m/f/d)

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description highlights opportunities to join a global consulting organization's Security Leadership Team, gain strategic insights, and advance as an IT Security Consultant. The role involves technical expertise, innovation, and collaboration across public and private sectors, with requirements including bachelor's degrees and fluency in English and German.

Package Consultant-SAP HANA FIN VIM

Company: IBM

Location: Pune, IN

Posted Dec 09, 2025

This text describes a career in IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI, and the role's focus on technical expertise and impactful solutions. It outlines responsibilities, required experience, and preferred skills for consultants working on complex projects with IBM's technology platforms.

DevOps Engineer

Company: IBM

Location: Cheltenham, GB

Posted Dec 09, 2025

IBM CIC offers a supportive environment with career growth, training, and innovative projects. The role involves DevOps expertise, collaboration with clients, and a focus on continuous learning and security practices.

Frequently Asked Questions

What are typical salary ranges by seniority in Submit Docs Spec roles?
Entry‑level Documentation Specialists earn $55,000–$70,000 annually. Mid‑level Coordinators and Technical Writers command $75,000–$95,000, while senior Regulatory Affairs Managers and Compliance Directors often reach $110,000–$140,000, depending on industry and geographic location.
Which skills and certifications are required?
Key skills include eCTD submission, ISO 9001/13485 documentation, GxP audit readiness, MasterControl or Sparta compliance software, and strong technical writing. Certifications such as Certified Regulatory Affairs Professional (CRA), Certified Quality Auditor (CQA), ISO 9001 Lead Auditor, and Six Sigma Green/Black Belt give candidates a competitive edge.
Is remote work available for Submit Docs Spec positions?
Yes, many employers support fully remote or hybrid models for documentation specialists and regulatory coordinators. Remote roles often rely on secure cloud platforms (e.g., SharePoint, Confluence, MasterControl) and virtual audit tools to maintain compliance.
What career progression paths exist?
Typical progression starts with Documentation Specialist → Regulatory Affairs Coordinator → Technical Writer → Regulatory Affairs Manager → Director of Compliance or Regulatory Affairs. Advancement often requires additional certifications and proven success managing multi‑regulatory submissions.
What are current industry trends affecting Submit Docs Spec roles?
Trends include AI‑driven document review for faster submission cycles, blockchain for immutable audit trails, regulatory sandboxes for digital health and medical devices, and increased focus on data privacy regulations like GDPR and CCPA. Professionals who stay current with these technologies will command higher salaries.

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