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.

Project Administrator-Project Support (Marisse Gueco)

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 17, 2025

IBM Consulting offers career opportunities focused on client collaboration, innovation, and growth. The role involves project management, technical expertise, and fostering creativity to drive meaningful change.

Advisory Visual Designer/Illustrator for Carbon Design System

Company: IBM

Location: Mulhuddart, IE

Posted Dec 17, 2025

The text describes IBM's Carbon Design System, an open-source design framework for creating consistent digital experiences. It outlines the role of a Visual Designer and Illustrator needed to evolve the system, emphasizing collaboration, accessibility, and scalable visual assets. The job requires expertise in typography, illustration, and design tools, with a focus on contributing to open-source communities and maintaining design standards across IBM's ecosystem.

Project Manager-SAP HANA ADM

Company: IBM

Location: Gurgaon, IN

Posted Dec 17, 2025

This job description highlights a Project Manager role at IBM Consulting, emphasizing collaboration with global clients, hybrid cloud/AI expertise, and career growth opportunities. Responsibilities include leading projects, managing teams, and delivering SAP solutions. Requirements include a bachelor's degree, SAP experience, and project management certifications.

Associate Application Developer- Azure Cloud FullStack

Company: IBM

Location: Perth, AU

Posted Dec 17, 2025

The text promotes IBM Consulting's Associate Program, emphasizing professional growth, global client collaboration, and innovative technology solutions. It highlights opportunities for career advancement, technical development, and impactful problem-solving in a supportive ecosystem.

DevSecOps Engineer Intern

Company: IBM

Location: Singapore, SG

Posted Dec 17, 2025

IBM seeks passionate interns to drive innovation and solve complex challenges, emphasizing technical skills and growth in a dynamic, inclusive environment.

Software Developer (f/m/x)

Company: IBM

Location: Ehningen, DE

Posted Dec 17, 2025

This job posting highlights opportunities to shape enterprise software development, collaborate with global teams, and make a significant impact on SAP solutions. The role emphasizes innovation, career growth, and working with cutting-edge technologies in a dynamic environment.

Senior Services Project Manager

Company: IBM

Location: MADRID, ES

Posted Dec 17, 2025

This job description highlights a senior project manager role at IBM Software, emphasizing collaboration on cloud-native solutions and managing complex projects. The position offers opportunities to work with cross-functional teams, deliver exceptional client experiences, and contribute to innovative AI-powered technologies. Requirements include PMP certification, bilingual skills, and experience with cloud transformation projects.

Application Developer-Open Source

Company: IBM

Location: Pune, IN

Posted Dec 17, 2025

The text promotes IBM Consulting's career opportunities, emphasizing collaboration, innovation, and growth. It highlights working with global clients on hybrid cloud and AI projects, leveraging IBM technology, and fostering a culture of curiosity and continuous improvement. Technical requirements include Python, Spark, and database expertise.

Industry Consultant-Banking

Company: IBM

Location: BANGALORE, IN

Posted Dec 17, 2025

This job description outlines a role at IBM Consulting's Client Innovation Centers, emphasizing opportunities for professional growth, technical expertise development, and collaboration with clients. Responsibilities include strategic solution leadership, team management, and comprehensive solution delivery. Required skills involve banking industry experience, Agile methodologies, and technical knowledge in data protection and encryption.

AR Contact Center Practitioner

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 17, 2025

This job description outlines a customer service role at IBM's consulting centers, emphasizing collaboration, innovation, and problem-solving. Responsibilities include handling customer inquiries, providing technical support, and ensuring satisfaction through effective communication and empathy. The position requires 12 years of call center experience, strong interpersonal skills, and adaptability to multishift environments.

Infrastructure Specialist Jnr.

Company: IBM

Location: BRATISLAVA, SK

Posted Dec 17, 2025

The job description outlines a TAM role at IBM Infrastructure & Technology, focusing on client support, technical expertise, and career growth. It highlights responsibilities, required skills, and preferred qualifications, emphasizing a supportive environment and opportunities for innovation.

Intern - Communication & Marketing

Company: IBM

Location: GRONINGEN, NL

Posted Dec 17, 2025

The text promotes IBM Consulting's career opportunities, emphasizing collaboration, innovation, and growth. It highlights roles in marketing, client engagement, and leveraging IBM's technology to drive impactful solutions while valuing employee development.

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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