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.

Delivery Consultant, CICS

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

This text describes a role at IBM Technology Expert Labs emphasizing collaborative innovation, technical expertise, and career growth. It highlights world-class services, positive impact on clients, and a supportive learning culture. The position requires specialized knowledge of IBM Z systems, CICS, and zOS programming, while offering opportunities to solve complex challenges and advance professionally.

Package Consultant-SAP FIN CO

Company: IBM

Location: BANGALORE, IN

Posted Dec 10, 2025

This job description outlines a role in IBM Consulting focused on hybrid cloud and AI initiatives, requiring technical expertise in SAP systems and collaboration with global clients. Responsibilities include system configuration, defect resolution, and testing, with qualifications emphasizing SAP S4HANA experience and technical consulting skills.

Software Engineer II - HashiCorp Terraform

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

This job description highlights opportunities to work on innovative cloud solutions with IBM's Terraform team, focusing on infrastructure management, customer outcomes, and professional growth. The role involves full-stack development, architectural decisions, and collaboration on cutting-edge technologies.

Technical Lead TS/SCI W/FSP

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

The text describes a career in IBM Consulting emphasizing collaboration with global clients, innovation in hybrid cloud and AI solutions, and professional growth opportunities. It highlights required expertise in technical leadership, system design, and security compliance, while promoting a culture of curiosity and continuous learning.

Application Developer-Oracle Cloud Reports

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 10, 2025

IBM Consulting offers career opportunities focused on client collaboration, innovation, and technical expertise. The role requires skills in Oracle Cloud reporting and problem-solving, with a culture emphasizing growth and creativity.

PROCESS DELIVERY SPECIALIST-TALENT DEVELOPMENT OPTIMIZATION PROCESSES

Company: IBM

Location: BANGALORE, IN

Posted Dec 10, 2025

This text describes a career opportunity in IBM Consulting focusing on long-term client relationships and digital transformation through agile methodologies. It outlines responsibilities involving HR system management, complex transactions, and compliance with client standards. The role emphasizes collaboration, problem-solving, and technical expertise in SAP HRMS and MS Excel, while highlighting career growth and strategic partnerships within IBM's ecosystem.

Java Software Developer - Product Operations Lead for Red Hat build of Apache Camel (m/f/x)

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

The role involves collaborating on AI-powered cloud-native solutions, customer-focused development, and technical expertise in Java and Apache Camel, with opportunities for growth and innovation.

Software Strategy and M&A Summer Intern - New York, NY

Company: IBM

Location: New York, US

Posted Dec 10, 2025

The Software Strategy and MampA intern will support growth initiatives, develop strategies, and collaborate with cross-functional teams. Key skills include data analysis, communication, and teamwork. The position is located in New York or Cambridge with mentorship opportunities.

SAP ABAP Developer (HANA)

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

This text describes a career in IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI, and technical expertise in SAP HANA development. It outlines role responsibilities, required skills, and professional growth opportunities within IBM's ecosystem.

Application Database Administrator-NoSQL Cloud Databases

Company: IBM

Location: Navi Mumbai, IN

Posted Dec 10, 2025

The role involves designing mobile solutions using Cassandra, collaborating with teams, and ensuring database performance and reliability through troubleshooting and continuous improvement.

Professional Services Sales Consultant (f/m/x)

Company: IBM

Location: Multiple Cities

Posted Dec 10, 2025

This job description highlights a career opportunity at IBM Software focusing on innovation, team collaboration, and professional growth. The role emphasizes transforming customer challenges into industry-leading solutions, with a strong emphasis on cloud-native AI technologies and global career opportunities. Responsibilities include sales pipeline management, customer engagement, and solution architecture, requiring expertise in technology sales and cross-functional collaboration.

Application Developer-Oracle Cloud Reporting

Company: IBM

Location: Hyderabad, IN

Posted Dec 10, 2025

The text describes a consultant role at IBM Consulting, emphasizing technical expertise, client collaboration, and innovation in delivering solutions. It outlines responsibilities such as developing user-centric solutions, managing risks, and ensuring timely delivery. Required qualifications include experience with Oracle technologies and cloud implementations, while preferred skills involve advanced technical training and integration expertise.

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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