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-SAP ABAP HANA

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

The text describes a career in IBM Consulting emphasizing collaboration with global clients, innovation in hybrid cloud and AI, professional growth opportunities, and technical expertise in SAP solutions. It highlights a supportive culture, strategic partnerships, and advanced technologies for impactful client outcomes.

Application Developer-Java & Web Technologies

Company: IBM

Location: Gurgaon, IN

Posted Dec 09, 2025

This role offers opportunities to work with global clients on innovative projects, emphasizing career growth and technical expertise in hybrid cloud and AI solutions. The position highlights collaboration with industry visionaries, strategic partner ecosystems, and advanced technology platforms while requiring strong technical skills in Java, Spring, and Hibernate.

Internship: SAP Consultant in Guadalajara, Mexico

Company: IBM

Location: GUADALAJARA, MX

Posted Dec 09, 2025

The text promotes an IBM Consulting internship offering career growth, client collaboration, and technical expertise. It highlights required qualifications and benefits of the program.

Application Developer-AWS Cloud FullStack

Company: IBM

Location: Mysore, IN

Posted Dec 09, 2025

This text describes a career in IBM Consulting, emphasizing collaboration with global clients, technical expertise in hybrid cloud and AI, and opportunities to drive innovation. It highlights the role's focus on solving client problems, building trust, and leveraging IBM's technology platforms for impactful outcomes.

Project Manager-Application Operations

Company: IBM

Location: Taipei, TW

Posted Dec 09, 2025

IBM Software careers offer opportunities to lead innovative projects, collaborate in agile teams, and drive cloud-native solutions with growth potential.

PROCESS DELIVERY SPECIALIST-PROCURE TO PAY

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This job description highlights a career in IBM Consulting focused on global client collaboration, digital transformation, and innovation. The role emphasizes long-term relationships, strategic partnerships, and career growth opportunities through technology platforms and mentorship. Responsibilities include vendor management, invoice processing, and compliance with SLAs, requiring technical expertise and adaptability.

Package Specialist-SAP Ariba

Company: IBM

Location: Ahmedabad, IN

Posted Dec 09, 2025

This job description outlines a role requiring SAP BASIS expertise, HANA migrations, cloud platform experience, and collaboration with global teams. It emphasizes technical skills in SAP versions, system setups, and integration with cloud services.

Quantum Engagement Lead - United States

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

IBM Quantum promotes collaboration with partners and institutions to advance quantum computing. The role emphasizes partnership success, innovation, and strategic initiatives while requiring strong project management and technical expertise.

Associate Application Consultant-AWS Cloud

Company: IBM

Location: Singapore, SG

Posted Dec 09, 2025

The text promotes IBM Consulting's Associate Program, emphasizing professional growth, global client collaboration, and opportunities to work on innovative technologies. It highlights career development, technical skills training, and the impact of solving complex client challenges through a culture of curiosity and continuous learning.

Senior Data Scientist - Artificial Intelligence

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description outlines a Senior Data Scientist role at IBM Consulting, emphasizing technical leadership, cross-functional collaboration, and innovation in AI initiatives. The position requires expertise in machine learning, data governance, and cloud technologies, with opportunities for career growth and impactful client work.

Package Consultant-SAP HANA FIN CO

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This text promotes a career in IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI solutions, and professional growth opportunities. It highlights the role of a senior SAP Consultant, required expertise in SAP technologies, and the importance of curiosity and problem-solving in delivering impactful results.

Senior Application Architect – Digital Engineering

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description outlines a Senior Application Architect role focused on defining and delivering PLM/Digital Engineering solutions, requiring technical leadership, mentoring, and expertise in Siemens Teamcenter. It emphasizes architectural design, system integration, and innovation in complex projects.

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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