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.

F&A Delivery Manager

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 09, 2025

The text describes a leadership role at IBM's consulting delivery centers, emphasizing innovation, client satisfaction, and operational excellence. It outlines responsibilities including team management, service delivery, and strategic planning, while highlighting required expertise in financial processes and large-scale project management.

Senior OCP Consultant

Company: IBM

Location: Krakow, PL

Posted Dec 09, 2025

The role offers career growth in a collaborative IBM environment, focusing on cloud technologies and client solutions with a positive impact.

Quality Engineer-Automation

Company: IBM

Location: Mumbai, IN

Posted Dec 09, 2025

This role involves working in IBM's delivery centers to deliver technical expertise and drive innovation through collaboration, training, and testing skills. Key responsibilities include team collaboration, technical training, and system integration.

Application Architect-SAP NextGen Technical Innovation

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This job description highlights a career in IBM Consulting focused on hybrid cloud and AI solutions, emphasizing collaboration with clients, technical leadership, and professional growth opportunities through SAP expertise and project management responsibilities.

Back End Developer (Early career)

Company: IBM

Location: GUADALAJARA, MX

Posted Dec 09, 2025

This job description highlights a backend developer role at IBM Systems focusing on software development for storage infrastructure. The position requires expertise in Python, Linux, and agile methodologies, while offering opportunities to innovate and collaborate with global teams on high-quality storage solutions.

Application Developer-Cloud FullStack

Company: IBM

Location: Hyderabad, IN

Posted Dec 09, 2025

This role offers opportunities to work globally with clients, lead innovative projects, and leverage advanced technologies for career growth.

Application Developer-Oracle Cloud Reporting

Company: IBM

Location: Gurgaon, IN

Posted Dec 09, 2025

This text describes a consultant role at IBM Consulting, emphasizing technical expertise, client collaboration, and career development opportunities. It outlines responsibilities such as solving business problems, developing scalable solutions, and meeting client specifications. The job requires a bachelor's degree, Oracle experience, and preferred skills in cloud technologies and integration tools.

Security Specialist-Infrastructure Security

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This job description outlines a role at IBM Consulting involving technical expertise in cloud engineering, system infrastructure, and CDN technologies. Responsibilities include optimizing technical infrastructure, analyzing data for decision-making, and managing system reliability. Requirements include a bachelor's degree, cloud platform experience, and strong analytical skills.

Application Architect-Salesforce

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

The text describes a career in IBM Consulting focused on global client collaboration, hybrid cloud and AI innovation, and technical expertise in Salesforce implementation. It highlights opportunities for impactful work with strategic partners and industry-specific expertise in sectors like banking.

Product Manager

Company: IBM

Location: Markham, CA

Posted Dec 09, 2025

The text describes a Product Manager role at IBM focused on leading observability for generative AI technologies. It highlights opportunities for innovation, collaboration with cross-functional teams, and requirements including expertise in AI monitoring tools, cloud-native systems, and agile practices. The role emphasizes driving product growth and staying ahead of industry trends in AI observability.

SAP ABAP HANA and Fiori Developer

Company: IBM

Location: Bucharest, RO

Posted Dec 09, 2025

This text describes a senior SAP Consultant role at IBM Consulting, emphasizing collaboration with clients, technical expertise in SAP technologies, and opportunities for professional growth across various industries and disciplines.

Associate Quality Engineer-Automation

Company: IBM

Location: BANGKOK, TH

Posted Dec 09, 2025

This job description highlights opportunities for career growth in IBM Consulting, emphasizing collaboration with global clients, impact on hybrid cloud and AI initiatives, and professional development. It outlines responsibilities as a Quality Engineer, required skills in software testing and cloud computing, and preferred experience with testing tools and data analysis.

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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