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.

Federal Enterprise Account Manager- Strategic Accounts (DC Metro)

Company: IBM

Location: Multiple Cities

Posted Dec 15, 2025

This text describes a job role for an Enterprise Account Manager requiring sales expertise in enterprise accounts, collaboration with partners like IBM and RedHat, and experience in specific government sectors. It outlines responsibilities such as pipeline generation, customer adoption, and strategic sales, along with educational and technical requirements.

Technology Project Manager

Company: IBM

Location: Multiple Cities

Posted Dec 15, 2025

This job posting highlights IBM's opportunity to work on transformative technologies and prestigious events like The Masters and Wimbledon. The role emphasizes collaboration, innovation, and delivering impactful digital fan experiences through project management and cross-functional teamwork.

Software Developer

Company: IBM

Location: Lucknow, IN

Posted Dec 15, 2025

The text highlights IBM's recruitment of skilled software developers for critical projects, emphasizing their role in creating industry-leading solutions and contributing to global initiatives. It outlines required technical expertise, tools, and the importance of automation and collaboration in high-profile projects.

Technical Consultant-AIOps

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This job description outlines a role as an AIOps Technical Consultant at IBM, focusing on driving digital transformation through AI and ML techniques. The position involves assessing client infrastructure, implementing AIOps platforms, and optimizing IT operations to enhance reliability and efficiency. Required skills include programming languages, NLU/NLP techniques, and certifications in ITIL/DevOps.

Application Developer-Microsoft Middleware

Company: IBM

Location: Gurgaon, IN

Posted Dec 15, 2025

This text describes a Software Developer role at IBM Consulting, focusing on hybrid cloud and AI solutions. It outlines responsibilities like software development, integration tasks, and collaboration with clients. Required skills include SAP BTP, Microsoft BizTalk, and cloud platform expertise, with preferred experience in SAP HANA Cloud and API testing tools.

Package Consultant-SAP HANA FIN FICA

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

The text describes a career in IBM Consulting focused on long-term client relationships and collaboration with global innovators. It highlights opportunities to work on hybrid cloud and AI projects, with responsibilities including SAP FICA implementation and project leadership. Required qualifications emphasize technical expertise in SAP Hana and experience with configuration, testing, and post-go-live support.

Package Specialist-Oracle Business Analytics

Company: IBM

Location: Pune, 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 the role of a consultant as a trusted advisor. It outlines responsibilities, required skills, and career growth opportunities within IBM's ecosystem.

Application Developer-Azure Cloud FullStack

Company: IBM

Location: Hyderabad, IN

Posted Dec 15, 2025

This text describes a career opportunity in IBM Consulting, emphasizing collaboration with global clients, hybrid cloud and AI innovation, and technical expertise in full-stack development with Azure and cloud-native technologies.

IT Recruiter (Process Delivery Specialist)

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

IBM Services seeks a Recruitment Specialist with experience in bulk hiring and ATS management. The role involves sourcing, screening, and coordinating candidates globally, emphasizing innovation and excellence through technology-driven methodologies.

Package Consultant-SAP HANA SCM SD

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This role involves collaborating with clients on SAP SD implementations, leading projects, and requiring a bachelor's degree with SAP experience. The position emphasizes technical expertise, system solutions, and working within IBM's ecosystem to drive innovation.

Quality Engineer-FullStack

Company: IBM

Location: BANGALORE, IN

Posted Dec 15, 2025

This role involves working with clients on hybrid cloud and AI projects, requiring expertise in testing and automation tools. It offers opportunities for innovation and collaboration with global teams.

Application Developer-SAP Enterprise Integration

Company: IBM

Location: QUEZON CITY, PH

Posted Dec 15, 2025

IBM Consulting offers a career focused on innovation and collaboration, emphasizing client relationships, technical expertise, and professional growth through strategic projects and global partnerships.

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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