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.

【東京】AWSプロジェクトマネージャー

Company: IBM

Location: Tokyo, JP

Posted Dec 23, 2025

This job description highlights a project management role at IBM focusing on AWS-based system development, client collaboration, and technological innovation. It emphasizes career growth opportunities, professional development, and the use of IBM's technology portfolio to drive business transformation.

Solution Architect

Company: IBM

Location: Houston, US

Posted Dec 23, 2025

The text describes a senior technical leadership role at IBM emphasizing innovation, strategic problem-solving, and impactful organizational change. It highlights responsibilities such as defining system architectures, leading technical decisions, and driving business outcomes through advanced analytics and technology adoption. Required expertise includes Databricks ecosystem proficiency, data governance, and consulting leadership skills with a focus on delivering measurable business results.

Data Engineer-Data Platforms-AWS

Company: IBM

Location: Pune, IN

Posted Dec 23, 2025

This job description outlines a Data Engineer role at IBM Consulting, requiring expertise in big data technologies like Spark, Hadoop, and Azure cloud platforms. Responsibilities include developing data solutions, building pipelines, and working with cloud ecosystems. Required skills involve experience with Python/Scala, SQL, and tools such as Kafka and DataBricks.

Data Engineer-Data Warehouse

Company: IBM

Location: BANGALORE, IN

Posted Dec 23, 2025

This job description outlines a role in IBM's delivery centers focusing on technical expertise, ETL workflows, and Agile methodologies. Responsibilities include system analysis, data modeling, and production support. Requirements emphasize technical skills, teamwork, and continuous learning.

Select Horizon Technology Sales Leader

Company: IBM

Location: Tokyo, JP

Posted Dec 23, 2025

This job posting highlights IBM's global sales role focusing on innovation, collaboration, and digital transformation. The position requires Japanese-speaking skills and emphasizes strategic thinking, relationship-building, and technology expertise. It offers opportunities for career growth and impactful business solutions across industries.

Delivery Consultant - zLinux

Company: IBM

Location: Multiple Cities

Posted Dec 23, 2025

The text promotes a career at IBM Technology Expert Labs, emphasizing collaborative innovation, career growth, and impactful problem-solving for clients. It highlights technical expertise, cross-functional teamwork, and opportunities to work on complex projects with global teams.

Industry Consultant-Banking

Company: IBM

Location: Pune, IN

Posted Dec 23, 2025

This job description outlines a role at IBM Consulting involving technical expertise in fraud management and enterprise solutions, requiring a bachelor's degree, Java technologies experience, and knowledge of UI development and web services.

Back-end Developer

Company: IBM

Location: BUDAPEST, HU

Posted Dec 23, 2025

The text describes a developer role involving feature development, code reviews, collaboration with cross-functional teams, maintaining services, documentation, and required expertise in technologies like TypeScript, Node.js, and cloud platforms. It emphasizes Agile methodologies and continuous learning.

Package Consultant-SAP HANA EPM

Company: IBM

Location: Shanghai, CN

Posted Dec 23, 2025

The text describes a career in IBM Consulting focused on collaborative client relationships, innovation in hybrid cloud and AI solutions, and professional growth opportunities. It highlights roles involving SAP expertise, strategic problem-solving, and technology integration across industries.

Technical Solution Architect

Company: IBM

Location: Armonk, US

Posted Dec 23, 2025

This job posting outlines a Technical Solution Architect role requiring a Bachelor's degree and experience with specific technologies. It details responsibilities, required skills, and a salary range of $150,550 to $194,500 per year.

Government and Policy Affairs Manager

Company: IBM

Location: CANBERRA, AU

Posted Dec 23, 2025

The text describes IBM's Legal Regulatory Affairs role, emphasizing innovation, integrity, and global collaboration. It outlines responsibilities involving government relations, policy influence, and supporting business growth through technology and compliance. Required qualifications include a bachelor's degree and expertise in government relations, with preferred skills in policy development and IT trends.

PROCESS DELIVERY SPECIALIST-LEAD TO CASH

Company: IBM

Location: BANGALORE, IN

Posted Dec 23, 2025

This role involves collaborating with global clients to drive digital transformation using agile methods and AI. It emphasizes long-term growth, innovation, and impactful solutions through strategic partnerships and technology platforms.

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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