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 Database Administrator-RDBMS

Company: IBM

Location: Pune, IN

Posted Dec 11, 2025

This job description outlines a role at IBM Consulting involving technical expertise in delivering solutions for public and private sector clients. Responsibilities include designing mobile applications, continuous improvement through agile frameworks, and implementing database technologies. Required skills focus on DB2, Linux, and database administration with expertise in performance tuning and troubleshooting.

Application Consultant-DevOps - OpenText APM Developer

Company: IBM

Location: NO City, BR

Posted Dec 11, 2025

The text describes a job role in IBM Consulting requiring expertise in OpenText APM, VuGen scripting, and cloud technologies. It outlines responsibilities like performance testing, monitoring, and collaboration with teams, while specifying technical requirements and preferred skills in observability tools and cloud ecosystems.

Application Developer-zOS

Company: IBM

Location: Hyderabad, IN

Posted Dec 11, 2025

The text describes a career in IBM Consulting emphasizing global collaboration, innovation in hybrid cloud and AI, technical expertise, and professional development opportunities. It outlines role responsibilities, required skills, and preferred qualifications for working with clients and technology platforms.

Software Engineer - Backend

Company: IBM

Location: Austin, US

Posted Dec 11, 2025

This job description outlines a Software Engineer role requiring expertise in Agile development, microservices, AWS, and DevOps tools. It emphasizes cross-functional collaboration, CI/CD pipelines, and proficiency in languages like Golang and Java. The position demands both technical skills and adaptability to business needs.

Consulting Senior Financial Analyst

Company: IBM

Location: Toronto, CA

Posted Dec 11, 2025

This job description outlines a Senior Financial Analyst role at IBM Canada Consulting, requiring financial analysis, communication skills, and leadership expertise. Key responsibilities include forecasting, contract analysis, and supporting business units. Required qualifications include a bachelor's degree and analytical skills.

Technical Lead Developer – Data Classification & Compliance

Company: IBM

Location: BANGALORE, IN

Posted Dec 11, 2025

This job description seeks a technical leader with expertise in mainframe systems and modern software development for data classification initiatives in the financial services industry. The role requires balancing technical leadership, compliance expertise, and secure architecture design for regulated projects, with emphasis on machine learning integration and security-by-design principles.

OpenShift System Engineer (m/w/d)

Company: IBM

Location: Multiple Cities

Posted Dec 11, 2025

The text describes a System Engineer role at IBM Consulting, emphasizing collaboration with global clients, technical expertise in hybrid cloud and AI, and requirements for skills in Red Hat OpenShift, Kubernetes, and GitOps. It highlights opportunities for innovation and impact through strategic technology platforms.

Technical Support engineer - PLM QM

Company: IBM

Location: GUADALAJARA, MX

Posted Dec 11, 2025

A career in IBM Consulting involves collaborating with global clients on hybrid cloud and AI projects, focusing on SAP HANA and Quality Management with technical expertise. The role emphasizes innovation, client impact, and working within strategic partner ecosystems to drive technological adoption.

Application Architect-Banking

Company: IBM

Location: Islamabad, PK

Posted Dec 11, 2025

This role involves designing banking applications and collaborating with stakeholders to enhance hybrid cloud and AI solutions, requiring expertise in core banking processes and cloud technologies.

Estágio em Pré-Vendas de Mainframe

Company: IBM

Location: SÃO PAULO, BR

Posted Dec 11, 2025

IBM seeks graduates with technical and interpersonal skills to collaborate on innovative solutions, emphasizing a supportive environment, career growth, and impactful client relationships.

Application Developer-ReactJS

Company: IBM

Location: BANGALORE, IN

Posted Dec 11, 2025

The text describes a job candidate's technical expertise in JavaScript, ReactJS, and cloud platforms, highlighting skills in frontend development, testing, and deployment strategies. It emphasizes experience with tools like Mocha, Jest, and Docker, along with work in IBM's delivery centers for client projects.

Application Developer-RDBMS

Company: IBM

Location: Mumbai, IN

Posted Dec 11, 2025

This role involves working with clients globally to develop customized systems using IBM's technology. It requires expertise in database design and agile methods, offering opportunities for innovation and career growth.

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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