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.

Package Consultant-SAP HANA FIN VIM

Company: IBM

Location: Kolkata, IN

Posted Dec 15, 2025

The text describes a career in IBM Consulting, emphasizing collaboration with global clients, technical expertise in hybrid cloud and AI, and responsibilities involving solution design, project management, and technology implementation. It highlights opportunities to work with innovative companies and deliver impactful results through IBM's ecosystem.

IT Lab Tech Apprentice

Company: IBM

Location: TUCSON, US

Posted Dec 15, 2025

The IBM Infrastructure Lab Technician Apprentice role offers hands-on experience in hardware support, learning opportunities, and career growth within a structured apprenticeship program. It emphasizes collaboration, technical skills development, and real-world application of knowledge in a dynamic work environment.

Fullstack Developer

Company: IBM

Location: Ahmedabad, IN

Posted Dec 15, 2025

The text describes a Software Developer role at IBM's Sustainability Software business unit, emphasizing collaboration with global teams, software delivery cycles, Agile methodologies, and required technical expertise in technologies like React, Java, and cloud platforms. It outlines responsibilities including system design, code reviews, and automated testing.

Site Reliability Engineer II (Apptio)

Company: IBM

Location: Krakow, PL

Posted Dec 15, 2025

IBM promotes a forward-thinking work environment where innovation and collaboration drive cloud technology leadership. The role of a Site Reliability Engineer involves maintaining cloud infrastructure, solving complex problems, and working across teams to deliver mission-critical services with a focus on reliability and performance.

Project Manager-SAP HANA

Company: IBM

Location: Taipei, TW

Posted Dec 15, 2025

This text describes a career opportunity in IBM Consulting, emphasizing strategic leadership in SAP solutions, team management, and comprehensive delivery of innovative technology implementations. It highlights required expertise in SAP systems, AI, and cybersecurity, while showcasing the impact of collaborative client relationships.

Application Developer-Microsoft Cloud

Company: IBM

Location: Gurgaon, IN

Posted Dec 15, 2025

This role involves collaborating with clients on hybrid cloud and AI projects using Microsoft technologies, requiring expertise in software development and agile practices. The position emphasizes innovation, technical collaboration, and career growth opportunities within IBM's global ecosystem.

SAP SD-SLS Support Technician

Company: IBM

Location: Multiple Cities

Posted Dec 15, 2025

This job description outlines a career in IBM Consulting focused on hybrid cloud and AI solutions, emphasizing collaboration with global clients, technical expertise in SAP modules, and contributions to innovation through IBM's technology platforms. Responsibilities include implementation, testing, and support of SAP systems, with requirements for a bachelor's degree and 14 years of experience in relevant technical areas.

Principal Engineer, HashiCorp Integrations

Company: IBM

Location: Multiple Cities

Posted Dec 15, 2025

This role involves leading AI-driven Terraform initiatives to enhance cloud solutions, focusing on agentic resource management and provider automation within IBM's Infrastructure Lifecycle team. The position emphasizes strategic leadership, innovation, and technical expertise to drive commercial differentiation and operational excellence.

Technical Consultant-IoT & Edge Computing

Company: IBM

Location: Gurgaon, IN

Posted Dec 15, 2025

IBM Consulting offers a career focused on innovation and collaboration, leveraging IoT and AI to drive digital transformation in the automotive industry. The role emphasizes technical expertise, analytical skills, and cross-functional teamwork to deliver impactful solutions for clients.

Business Transformation Consultant-IoT & PLM

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This job description outlines a role at IBM Consulting involving technical expertise in ARAS PLM implementation, requirements gathering, and development projects. It specifies educational requirements, technical skills in SQL server and PLM concepts, and preferred qualifications like a master's degree and ARAS customization experience.

PROCESS DELIVERY SPECIALIST-LEASE AND CONTRACT ADMINISTRATION

Company: IBM

Location: Chennai, IN

Posted Dec 15, 2025

This job description highlights a career in IBM Consulting focused on digital transformation through collaboration with global clients. It emphasizes opportunities for growth, strategic partnerships, and impactful work in hybrid cloud and AI initiatives. The role requires expertise in learning administration, technical skills, and strong communication abilities.

Java Developer - Japanese Bilingual

Company: IBM

Location: Multiple Cities

Posted Dec 15, 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 the role's focus on technical expertise, problem-solving, and impactful work with cutting-edge technologies, while also outlining required skills and preferred qualifications.

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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