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.

Application Developer-Microsoft Power Platform

Company: IBM

Location: BANGALORE, IN

Posted Dec 16, 2025

The text promotes IBM Consulting's career opportunities, emphasizing long-term client relationships, collaboration, innovation, and professional growth. It highlights roles in hybrid cloud and AI solutions, technical expertise, and a supportive work environment that encourages creativity and problem-solving.

Package Specialist-SAP HANA FIN FI

Company: IBM

Location: Kolkata, IN

Posted Dec 16, 2025

This job description highlights a career in IBM Consulting focused on hybrid cloud and AI solutions, emphasizing collaboration with global clients, technical expertise in SAP systems, and leadership in complex projects. It outlines requirements for experience with SAP FICO, S4HANA implementations, and cross-functional teamwork.

Business Analyst

Company: IBM

Location: Pune, IN

Posted Dec 16, 2025

The role emphasizes innovation, collaboration, and solving complex problems, requiring expertise in HRIS and SAP SuccessFactors.

Production Engineer

Company: IBM

Location: Markham, CA

Posted Dec 16, 2025

This job description highlights a career at IBM Software focused on transforming customer challenges into solutions through innovative AI-powered cloud-native software. The role involves ensuring platform reliability, automating operations, and collaborating across teams to enhance stability. It emphasizes expertise in Kubernetes, infrastructure as code, and monitoring tools, while offering growth opportunities in a dynamic, innovation-driven environment.

Application Developer Intern - Cloud FullStack

Company: IBM

Location: Giza, EG

Posted Dec 16, 2025

The text promotes IBM Consulting's career opportunities, emphasizing collaboration with leading companies, innovative solutions, and professional growth. It highlights roles in fullstack development with cutting-edge technologies and a supportive culture focused on long-term career development.

User Researcher

Company: IBM

Location: Multiple Cities

Posted Dec 16, 2025

IBM CIC offers extensive career growth opportunities, supportive work environments, and diverse benefits including training programs, flexible working arrangements, and career development resources. The company emphasizes innovation, collaboration, and employee well-being through various initiatives and recognition programs.

Techlead - BPOD - Automation

Company: IBM

Location: RIO DE JANEIRO, BR

Posted Dec 16, 2025

This text describes a career opportunity at IBM Consulting focusing on hybrid cloud and AI solutions, emphasizing collaboration, innovation, and professional growth. The role involves leading automation teams, technical project management, and integrating systems while leveraging IBM technologies. Required skills include experience with automation tools, programming languages, and data analysis, alongside business and behavioral competencies.

Application Developer-Process Management (BPM)

Company: IBM

Location: BANGALORE, IN

Posted Dec 16, 2025

This text describes a Data Engineer role at IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI, and expertise in BPM tools. It outlines responsibilities involving data management, workflow design, and integration with enterprise systems, along with educational and technical requirements for the position.

Application Consultant-Azure Cloud Migration

Company: IBM

Location: Gurgaon, IN

Posted Dec 16, 2025

IBM Consulting offers career growth through client collaboration on hybrid cloud and AI projects, emphasizing innovation and technical expertise. The role involves leading migration solutions, fostering client relationships, and driving impactful technological advancements with a focus on long-term development.

Package Specialist-SAP IS Utilities

Company: IBM

Location: Kolkata, IN

Posted Dec 16, 2025

The text promotes IBM Consulting's career opportunities, emphasizing collaboration, innovation, and growth in hybrid cloud and AI solutions. It highlights roles involving SAP-based utilities projects, technical expertise, and career development in a supportive environment.

Application Developer-Process Management (BPM)

Company: IBM

Location: BANGALORE, IN

Posted Dec 16, 2025

This text describes a Software Developer role at IBM Consulting, emphasizing collaboration with global clients, hybrid cloud and AI innovation, and opportunities to create impactful solutions through strategic technology platforms and partner ecosystems.

Front End Developer (React JS and .NET)

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 16, 2025

The text describes a Software Developer role at IBM Consulting, emphasizing hybrid cloud and AI project development, collaboration with global clients, and career growth opportunities. It highlights technical skills required, such as React JS and Agile methodologies, while promoting a culture of innovation and professional development.

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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