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 Specialist-SAP HANA SCM PP

Company: IBM

Location: Pune, IN

Posted Dec 15, 2025

This job description outlines a role at IBM Consulting involving technical expertise in SAP PP modules, project leadership, testing, and collaboration with clients. Requirements include a bachelor's degree, 6+ years of SAP experience, and skills in configuration, testing, and post-implementation support.

Infrastructure Specialist-Azure DevOps

Company: IBM

Location: Pune, IN

Posted Dec 15, 2025

This job description outlines a role at IBM Consulting's delivery centers, focusing on technical expertise in DevOps, Python, Kubernetes, and cloud technologies. It lists educational requirements, preferred qualifications, and experience in application security and distributed systems.

Linux Distro/system Development Engineer

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This job posting seeks a Linux Distribution Systems developer to maintain Debian packages for IBMZ compilers and toolchain components. Responsibilities include collaborating with internal teams, upstream projects, and the Debian community. Requirements emphasize experience with Linux packaging tools, system programming, and open-source coordination.

Package Consultant-Oracle Enterprise Performance Management Cloud

Company: IBM

Location: Gurgaon, IN

Posted Dec 15, 2025

The text describes a career in IBM Consulting focused on hybrid cloud and AI innovation, emphasizing collaboration with global clients, technical expertise, and career growth opportunities. It outlines required skills, responsibilities, and the role of a consultant as a trusted advisor.

Application Architect-Microsoft Business Applications

Company: IBM

Location: Gurgaon, IN

Posted Dec 15, 2025

The text describes a career in IBM Consulting focused on long-term client relationships, global collaboration, and technical expertise in hybrid cloud and AI solutions. It outlines role responsibilities, required skills in X++/C, technical design, and integration tools, along with preferred experience in lifecycle services and cloud platforms.

Application Developer-Azure Cloud FullStack

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This text describes a career in IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI, and technical expertise in software development. It outlines required skills in .NET Core, Angular, Azure platforms, and cloud-native deployment, along with preferred qualifications like a Master's degree and Agile team experience.

Fullstack Developer: React& NodeJs

Company: IBM

Location: Bucharest, RO

Posted Dec 15, 2025

This job posting seeks a skilled FrontEnd Developer for a headless commerce role, emphasizing expertise in modern frameworks, API integration, and performance optimization. It outlines responsibilities, required skills, and preferred experiences while highlighting collaboration and innovation in eCommerce solutions.

Infrastructure Specialist-ServiceNow

Company: IBM

Location: Pune, IN

Posted Dec 15, 2025

This job description outlines an Associate Developer role at IBM Consulting, focusing on client collaboration, solution development, and technical expertise in areas like ServiceNow. It lists required education, technical skills, and preferred certifications for the position.

Technical Consultant - Application Security

Company: IBM

Location: Mumbai, IN

Posted Dec 15, 2025

This text describes a career in IBM Consulting focused on hybrid cloud and AI innovation, emphasizing collaboration with global clients, strategic partnerships, and professional growth opportunities. It outlines responsibilities in application security, risk mitigation, and compliance with industry standards, while highlighting required expertise in security tools and frameworks.

Test Developer (f/m/x)

Company: IBM

Location: WIEN, AT

Posted Dec 15, 2025

This job description highlights a career in IBM Consulting focused on hybrid cloud and AI innovation, emphasizing collaboration with global clients, technical expertise, and career growth opportunities. It outlines responsibilities in test automation, agile development, and quality assurance, along with competitive compensation and inclusive work environment benefits.

Business Analyst-2025 graduate

Company: IBM

Location: Multiple Cities

Posted Dec 15, 2025

The text describes the role of a business analyst in bridging business and technical needs, emphasizing their impact on organizational efficiency, decision-making, and strategic direction. It outlines key responsibilities like requirements gathering, data analysis, and process improvement, along with required education and skills.

Package Consultant-SAP HANA SCM MM

Company: IBM

Location: Kolkata, IN

Posted Dec 15, 2025

This text describes a career opportunity at IBM Consulting focusing on SAP implementation and client collaboration. It highlights roles in project leadership, technical expertise, and innovation across global delivery centers, emphasizing career growth and impactful client solutions.

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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