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Regulatory Affairs Specialist

NexInfo Solutions, Inc.

San Francisco, California • 4d ago

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Contracts & Program Specialist

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Remote • 30+d ago

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Acumatica Implementation Specialist

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Calypso Configuration Specialist

Purview Infotech

Remote • 11d ago

Contract, Third Party

$60 - $70

W2 :: Remote :: VistA/MUMPS Healthcare Applications Support Specialist || G.C / U.S.C

Bitsoft International, Inc.

Remote • 2d ago

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Depends on Experience

Operations Specialist

Nextgen Information Services

Remote • 18d ago

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Contract

25 - 30

Export Control Specialist

Vaco by Highspring

Richmond, California • 19d ago

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Full-time

Depends on Experience

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Russell, Tobin & Associates

San Francisco, California • 12d ago

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Remote • 10d ago

Easy Apply

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Strategic Planning Specialist

System One

Remote • 17d ago

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Contract

Depends on Experience

Engineering Licensed Specialist 14 - Project Director

State of Michigan

Remote or Lansing, Michigan • Today

Full-time

USD 47.23 - 68.21 per hour

Engineering Licensed Specialist 14 - Project Director

State of Michigan

Remote or Detroit, Michigan • Today

Full-time

USD 47.23 - 68.21 per hour

eDiscovery Specialist

GDH

Remote • 10d ago

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Third Party, Contract

Depends on Experience

Corporate Communications Specialist

Eliassen Group

Remote or Almont, Colorado • Today

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Configuration Manager and Documentation Specialist / Tech Writer

9th Way Insignia

Remote • 16d ago

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Data Governance Specialist

Redef Corp

San Francisco, California • 17d ago

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Contract

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Appeals Creation Specialist

The Intersect Group

Remote • 3d ago

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Contract

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IT Application Development (Senior Specialist)

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

IT Application Development - Senior/Specialist

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

Applications Support Supervisor (IT Application Development Senior/Specialist)

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

Fireblocks Implementation Specialist Developer

Purview Services

Hybrid in San Francisco, California • 9d ago

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Product Support Specialist: Remote

Russell, Tobin & Associates

San Francisco, California • 25d ago

Easy Apply

Contract, Third Party

$70 - $75

Accounts Payable Specialist

Russell, Tobin & Associates

San Francisco, California • 5d ago

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Third Party, Contract

$70 - $80

Contingent Workforce Specialist

Horizontal Talent

Foster City, California • Today

Full-time

USD 52.00 - 55.00 per hour

Associate Technical Support Specialist

Milestone Technologies, Inc.

San Francisco, California • Today

Full-time

USD 27.31 - 28.65 per hour

Job Details

Skills

Regulatory Affairs
CMC

Summary

About Nexinfo
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors.
We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as inventory management,
product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Job Title: Regulatory Affairs Analyst

Position Summary

The Regulatory Affairs Active Dossier & Process Analyst will support regulatory document management and business process activities. The role will focus primarily on mapping existing document types to Active Dossier templates, establishing baseline documentation for Regulatory Affairs, and supporting updates to procedural documents and shared regulatory workflows.

Key Responsibilities

Review regulatory document types and map them to the appropriate Active Dossier templates.
Document mapping decisions, gaps, inconsistencies, and items requiring subject-matter expert confirmation.
Assist with establishing a baseline inventory of current Kite Regulatory Affairs documents.
Coordinate with regional regulatory leads to identify, collect, and validate current documents.
Support business process analysis, including documenting current-state activities and identifying standardization opportunities.
Update procedural and process documentation related to IDMP activities.
Assist in separating or revising shared WRKs used by Gilead CMC Regulatory Affairs
Draft and revise process maps, procedures, work instructions, trackers, and supporting documentation.
Maintain traceability among source documents, Active Dossier templates, business processes, and procedural updates.
Facilitate reviews with business owners and subject-matter experts and incorporate their feedback.
Track assignments, decisions, dependencies, open questions, and approvals.
Ensure deliverables follow applicable document-management, version-control, and quality standards.
Escalate unclear ownership, conflicting requirements, and documentation gaps to the appropriate business lead.

Expected Deliverables

Gilead/Kite document-type-to-Active-Dossier-template mapping.
Document inventory and baseline assessment for Kite Regulatory Affairs.
Mapping gap and decision log.
Current-state and proposed process documentation.
Updated Kite IDMP process documentation.
Revised or separated shared Gilead CMC RA and Kite WRKs.
Status tracker showing progress, dependencies, owners, and outstanding decisions.

Required Qualifications

Bachelor s degree or equivalent relevant professional experience.
Experience in Regulatory Affairs, regulatory operations, document management, quality, or business process analysis.
Experience working in a pharmaceutical, biotechnology, life-sciences, or similarly regulated environment.
Strong document analysis, classification, mapping, and organizational skills.
Experience drafting or updating procedures, work instructions, process maps, and controlled documents.
Ability to work with regional leads and subject-matter experts to gather and validate information.
Strong written communication and attention to detail.
Ability to work independently, manage competing priorities, and clearly document assumptions and decisions.
Proficiency with Microsoft Word, Excel, PowerPoint, and process or document-management tools.

Preferred Qualifications

Familiarity with Active Dossier or comparable regulatory information-management platforms.
Knowledge of regulatory dossier structures and document taxonomies.
Experience supporting Kite, Gilead, or comparable cell-therapy and pharmaceutical regulatory organizations.
Familiarity with IDMP processes and documentation.
Experience with CMC Regulatory Affairs.
Familiarity with controlled-document governance, change control, and version management.
Experience working across global or regional regulatory teams.

Working Model

The role will initially focus on document mapping and early business-process assignments.
The individual will work under the direction of designated Regulatory Affairs business owners.
Regional leads and subject-matter experts will identify or validate source documents and approve business-content decisions.
Responsibilities may expand depending on document volume, process-documentation needs, and procedural updates.

Thanks and Regards,

Joseph

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: nexinfo
Position Id: 9043997
Posted 30+ days ago

Fitment

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Contact the job poster

Joseph Thambi

Recruiter @ NexInfo Solutions, Inc.

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Job Details

Skills

Regulatory Affairs
CMC

Summary

Job Title: Regulatory Affairs Analyst

Position Summary

Key Responsibilities

Review regulatory document types and map them to the appropriate Active Dossier templates.
Document mapping decisions, gaps, inconsistencies, and items requiring subject-matter expert confirmation.
Assist with establishing a baseline inventory of current Kite Regulatory Affairs documents.
Coordinate with regional regulatory leads to identify, collect, and validate current documents.
Support business process analysis, including documenting current-state activities and identifying standardization opportunities.
Update procedural and process documentation related to IDMP activities.
Assist in separating or revising shared WRKs used by Gilead CMC Regulatory Affairs
Draft and revise process maps, procedures, work instructions, trackers, and supporting documentation.
Maintain traceability among source documents, Active Dossier templates, business processes, and procedural updates.
Facilitate reviews with business owners and subject-matter experts and incorporate their feedback.
Track assignments, decisions, dependencies, open questions, and approvals.
Ensure deliverables follow applicable document-management, version-control, and quality standards.
Escalate unclear ownership, conflicting requirements, and documentation gaps to the appropriate business lead.

Expected Deliverables

Gilead/Kite document-type-to-Active-Dossier-template mapping.
Document inventory and baseline assessment for Kite Regulatory Affairs.
Mapping gap and decision log.
Current-state and proposed process documentation.
Updated Kite IDMP process documentation.
Revised or separated shared Gilead CMC RA and Kite WRKs.
Status tracker showing progress, dependencies, owners, and outstanding decisions.

Required Qualifications

Bachelor s degree or equivalent relevant professional experience.
Experience in Regulatory Affairs, regulatory operations, document management, quality, or business process analysis.
Experience working in a pharmaceutical, biotechnology, life-sciences, or similarly regulated environment.
Strong document analysis, classification, mapping, and organizational skills.
Experience drafting or updating procedures, work instructions, process maps, and controlled documents.
Ability to work with regional leads and subject-matter experts to gather and validate information.
Strong written communication and attention to detail.
Ability to work independently, manage competing priorities, and clearly document assumptions and decisions.
Proficiency with Microsoft Word, Excel, PowerPoint, and process or document-management tools.

Preferred Qualifications

Familiarity with Active Dossier or comparable regulatory information-management platforms.
Knowledge of regulatory dossier structures and document taxonomies.
Experience supporting Kite, Gilead, or comparable cell-therapy and pharmaceutical regulatory organizations.
Familiarity with IDMP processes and documentation.
Experience with CMC Regulatory Affairs.
Familiarity with controlled-document governance, change control, and version management.
Experience working across global or regional regulatory teams.

Working Model

The role will initially focus on document mapping and early business-process assignments.
The individual will work under the direction of designated Regulatory Affairs business owners.
Regional leads and subject-matter experts will identify or validate source documents and approve business-content decisions.
Responsibilities may expand depending on document volume, process-documentation needs, and procedural updates.

Thanks and Regards,

Joseph

Dice Id: nexinfo
Position Id: 9043997
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Contact the job poster

Joseph Thambi

Recruiter @ NexInfo Solutions, Inc.

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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