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.

SAP Complex Project Manager

Company: IBM

Location: COPENHAGEN, DK

Posted Dec 23, 2025

This job description highlights a career in IBM Consulting with opportunities to work on hybrid cloud and AI projects globally, collaborate with industry leaders, and leverage IBM's technology platforms. The role emphasizes leadership in SAP project management, cross-functional teamwork, and client success. Benefits include professional growth, training access, and a supportive work environment with global networking opportunities.

Software Manager Exchange

Company: GHX

Location: Louisville

Posted Dec 22, 2025

The role involves leading a development team, designing technical roadmaps, and mentoring peers in an Agile environment using technologies like Angular and Java on AWS.

Software Developer (UI) AI Center of Excellence

Company: IBM

Location: BANGALORE, IN

Posted Dec 23, 2025

The text describes a job opportunity for an AI and Cloud Software Engineer at IBM's Infrastructure AI Center of Excellence. It outlines core objectives of velocity and safety, responsibilities involving AI development, cloud technologies, and collaboration, along with required skills in AI frameworks, cloud platforms, and programming languages. The role emphasizes innovation, continuous learning, and working in agile environments.

Senior Design Manager - Reporting

Company: HubSpot

Location: Remote

Posted Dec 22, 2025

This job description highlights a mission-driven UX role at HubSpot, emphasizing collaboration, product innovation, and fostering inclusive teams. It outlines opportunities to shape product strategy, work on impactful projects, and contribute to a psychologically safe work environment with competitive compensation.

Project Coordinator Consultant (PMO)

Company: IBM

Location: Aarhus, DK

Posted Dec 23, 2025

This job description highlights a role at IBM's Client Innovation Center involving project coordination and collaboration with clients. It emphasizes opportunities for professional growth, access to training, and a supportive work environment with global networking prospects.

Software Engineer Infrastructure

Company: xAI

Location: Palo Alto

Posted Dec 22, 2025

xAI seeks infrastructure engineers to build scalable AI systems, emphasizing innovation, collaboration, and excellence in a flat organizational structure.

Senior SAP Application Integration Consultant

Company: IBM

Location: Cairo, EG

Posted Dec 23, 2025

The text describes a career in IBM Consulting focused on long-term client relationships and collaboration, emphasizing hybrid cloud and AI solutions. It highlights the SAP Integration Manager role, requiring expertise in SAP S4HANA processes and cross-functional integration, along with leadership and analytical skills. The company promotes growth, empathy, and innovation in its culture.

Application Developer-Cloud FullStack

Company: IBM

Location: Pune, IN

Posted Dec 23, 2025

The text describes a career in IBM Consulting focused on global client collaboration, hybrid cloud and AI innovation, and technical development roles requiring expertise in Java, cloud platforms, and DevOps tools. It highlights opportunities for impactful work with strategic partners and technology ecosystems.

Staff Software Engineer Backend

Company: Leona Health

Location: San Francisco

Posted Dec 22, 2025

Leona aims to transform healthcare access through AI-driven tools, empowering doctors and patients with efficient communication. Backed by top investors, they seek experienced engineers to scale their innovative platform.

Senior AWS Cloud Full Stack Developer - Defence

Company: IBM

Location: London, GB

Posted Dec 23, 2025

IBM CIC offers extensive career growth, training, and a supportive work environment with benefits like flexible working and professional development opportunities.

Security Consultant - Threat Intel / Threat Hunt

Company: IBM

Location: Pune, IN

Posted Dec 23, 2025

This text describes a career in IBM Consulting focused on cybersecurity roles involving threat detection, incident response, and research. It highlights opportunities for professional growth, collaboration with global clients, and the use of advanced technologies. Requirements include a bachelor's degree, cybersecurity experience, and technical skills in threat hunting and analysis.

Performance Application Engineer Intelligent Factory

Company: Intrinsic

Location: Mountain View

Posted Dec 22, 2025

Intrinsic, part of Alphabet, seeks a Performance Application Engineer to enhance industrial robotics through AI and data. Responsibilities include testing and optimization, requiring expertise in robotics, programming, and automation.

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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