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.

SAP CRM Lead

Company: IBM

Location: Multiple Cities

Posted Dec 16, 2025

This job description highlights a career in IBM Consulting focused on hybrid cloud and AI projects with global clients. The SAP CRM Lead role involves managing CRM projects, collaborating with stakeholders, and implementing solutions using SAP technologies. The position offers flexibility to work from anywhere in the US.

Senior Financial Analyst

Company: IBM

Location: Mexico City, MX

Posted Dec 16, 2025

IBM Consulting offers a career focused on client collaboration and innovation, with opportunities for growth and impactful projects in hybrid cloud and AI. Responsibilities include financial analysis, strategic planning, and cross-functional teamwork.

Package Specialist-Oracle EPM

Company: IBM

Location: Pune, IN

Posted Dec 16, 2025

IBM Consulting offers career growth through client collaboration and innovation. The role involves technical expertise in HFM and FDMEE, with focus on delivering solutions and ensuring project success.

Electrical Engineer

Company: IBM

Location: Yorktown Heights, US

Posted Dec 16, 2025

This job description outlines the responsibilities of an Electrical Engineer supporting electrical design and operations in critical facilities. Key duties include maintaining electrical infrastructure reliability, managing maintenance tasks, ensuring compliance with safety codes, and collaborating with vendors. The role requires 8+ years of experience, technical expertise in electrical systems, and strong communication skills.

Operations Buyer

Company: IBM

Location: BANGALORE, IN

Posted Dec 16, 2025

IBM Finance & Operations drives efficiency and innovation, offering career growth in a collaborative global environment.

Sr Engineering Manager, Security Engineering

Company: IBM

Location: BANGALORE, IN

Posted Dec 16, 2025

This job description outlines a Sr Manager role focused on vulnerability management and compliance automation for HashiCorp's products. The position requires leadership in security programs, collaboration with cross-functional teams, and expertise in cloud-native architectures. Key responsibilities include designing security tools, managing risk posture, and contributing to strategic planning.

Consultant - SAP FICO/MM/SD/PP/EWM/TM/ABAP

Company: IBM

Location: Multiple Cities

Posted Dec 16, 2025

The text describes a career in IBM Consulting emphasizing collaboration with global clients, innovation in hybrid cloud and AI, leadership opportunities, and professional growth through SAP expertise and technology platforms. It highlights strategic roles, team leadership, and skill development in a supportive ecosystem.

Package Specialist-Oracle Business Analytics

Company: IBM

Location: Mumbai, IN

Posted Dec 16, 2025

This job description outlines a Consultant role at IBM Consulting, involving software development for hybridcloud and AI initiatives, with responsibilities spanning the software development lifecycle. Required qualifications include a bachelor's degree, experience with database migration, API integration, and continuous learning, along with preferred skills in risk management and quality assurance.

Package Specialist-SAP HANA FIN FI

Company: IBM

Location: Kolkata, IN

Posted Dec 16, 2025

This job description highlights a career in IBM Consulting focused on hybrid cloud and AI solutions, emphasizing collaboration, innovation, and technical expertise. It outlines responsibilities involving SAP implementation and requires extensive experience with SAP FICO and global team collaboration.

Endpoint Security SME

Company: IBM

Location: Pune, IN

Posted Dec 16, 2025

This job description outlines a role in IBM Consulting focused on security expertise, collaboration with global teams, and driving innovation in hybrid cloud and AI solutions. Responsibilities include managing endpoint security tools, SIEM analysis, threat intelligence, and maintaining compliance while fostering long-term client relationships.

Digital Professional - CONTRACTOR CONVERSION

Company: IBM

Location: SÃO PAULO, BR

Posted Dec 16, 2025

IBM promotes innovation and positive impact through technology. The role involves quality assurance, testing, and collaboration to ensure product excellence.

Early Associates Internship: Strategy & Transformation

Company: IBM

Location: MADRID, ES

Posted Dec 16, 2025

This job opportunity at IBM Consulting offers a career focused on hybrid cloud and AI transformation, emphasizing collaboration with global clients and organizational change strategies. Candidates will support HR transformation projects, requiring analytical skills, bilingual proficiency, and a proactive attitude.

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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