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.

Data Engineer

Company: IBM

Location: Vilnius, LT

Posted Dec 09, 2025

This job description outlines a role at IBM Consulting involving data processing systems development, collaboration with cross-functional teams, and expertise in technologies like Python, Apache Spark, and cloud platforms. It specifies educational requirements, technical skills, and salary range for the position.

Technical Support Representative (Tester)

Company: IBM

Location: Kaohsiung, TW

Posted Dec 09, 2025

This role involves collaborating with clients on system testing and innovation, offering growth opportunities in a supportive environment with emphasis on technical expertise and remote collaboration.

Package Consultant-SAP HANA Master Data Governance

Company: IBM

Location: Multiple Cities

Posted Dec 09, 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.

Package Consultant-Oracle Cloud HCM

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This text describes a career in IBM Consulting, emphasizing collaboration with global clients, innovation in hybrid cloud and AI solutions, and opportunities for long-term growth. It highlights the role's focus on technical expertise, client relationships, and problem-solving through IBM's technology platforms.

Security Consultant - Biometrics

Company: IBM

Location: Mumbai, IN

Posted Dec 09, 2025

This job description highlights IBM Consulting's focus on innovation, client collaboration, and career growth. It emphasizes working with global clients on hybrid cloud and AI solutions, supported by IBM's technology ecosystem. The role requires technical expertise in biometrics, endpoint management, and scripting, with opportunities for professional development.

Package Consultant-SAP SCM SD

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This job description outlines a senior SAP Consultant role at IBM Consulting, focusing on delivering technical expertise and innovative solutions to clients. Responsibilities include strategic SAP solution design, comprehensive delivery, and collaboration with clients. Requirements include extensive SAP experience, specific technical skills, and educational qualifications.

Package Consultant-SAP HANA FIN FI

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

The text describes a career in IBM Consulting focused on global client collaboration, innovation in hybrid cloud and AI, and working within strategic delivery centers. It highlights opportunities to drive technological adoption and emphasizes required expertise in SAP HANA and technical skills development.

Werkstudent - IT Security / SAP Security (m/w/d)

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This job description outlines a role in a global consulting organization's Security Leadership Team, offering strategic and administrative support, career advancement opportunities, and collaboration in innovative projects across public and private sectors. It emphasizes technical expertise, consulting experience, and bilingual proficiency.

Delivery Consultant for Infrastructure Automation and FinOps

Company: IBM

Location: Ljubljana, SI

Posted Dec 09, 2025

This text promotes a career opportunity at IBM Technology Expert Labs, emphasizing collaborative innovation, professional growth, and impactful problem-solving through infrastructure automation and DevOps expertise. It highlights a supportive learning culture, technical development, and contributions to clients' business success.

Lead Logic Design - CORE EXE (VSU) Unit

Company: IBM

Location: BANGALORE, IN

Posted Dec 09, 2025

This text describes a Hardware Engineer role at IBM Systems Lab involving quantum computing and AI hardware development. The position requires designing high-performance processors, collaborating with cross-functional teams, and possessing expertise in CPU architecture. Qualifications include advanced degrees, experience with processor cores, and knowledge of industry microprocessor designs.

Package Consultant-Oracle SCM

Company: IBM

Location: Kolkata, IN

Posted Dec 09, 2025

This text describes a consulting role at IBM focusing on hybrid cloud and AI solutions, emphasizing collaboration with clients, innovative problem-solving, and career growth opportunities. It outlines responsibilities, required expertise in Oracle technologies, and preferred qualifications for success in the position.

Software Developer - L3 Engineer

Company: IBM

Location: Mulhuddart, IE

Posted Dec 09, 2025

This job description outlines a role requiring advanced technical expertise in software development and support, with responsibilities including troubleshooting complex issues, collaborating with cross-functional teams, and mentoring junior engineers. The position emphasizes strong analytical skills, proficiency in specific technologies, and experience with Agile methodologies.

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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