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Regulatory Affairs Specialist

NexInfo Solutions, Inc.

San Francisco, California • 4d ago

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$60 - $70

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Regulatory Specialist

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Remote • 12d ago

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Depends on Experience

Rights & Restrictions Specialist

Pyramid Consulting, Inc.

Akron, Ohio • 16d ago

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Procurement Specialist (Level 1)

Key Infotek LLC

Wyoming, Ohio • 3d ago

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Contract, Third Party

Depends on Experience

EGID Call Center Specialist - Temporary

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Oklahoma City, Oklahoma • 9d ago

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$40 - $50

COMMUNICATIONS SPECIALIST

NodeLogix

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Product Compliance Specialist

BCforward

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Contracts & Program Specialist

Johnson Technology Systems Inc (JTSI)

Remote • 30+d ago

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$30 - $40

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Dexian DISYS

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$80000 - $120000 per annum

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WinMax Systems Corporation

Alpharetta, Georgia • 5d ago

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Contract

17 - 18

Market Transaction Specialist/Utility Billing Systems Analyst

Tandym Tech

Cedar Park, Texas • Today

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$60 - $60 per hour

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Wissen Infotech

Pittsburgh, Pennsylvania • Today

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Acumatica Implementation Specialist

Oscar Technology

Remote • Today

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$100000 - $110000 per annum

NOC Specialist

Stellar Professionals LLC

Hybrid in Harrisburg, Pennsylvania • 6d ago

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Third Party, Contract

$23 - $24

Assistant GIS Specialist

Randstad Digital

Akron, Ohio • Today

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Telecom Escalations Specialist

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Almont, Colorado • Today

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Stefanini

Houston, Texas • Today

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Epicor Technical Specialist

Oscar Technology

New Oxford, Pennsylvania • Today

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$100000 - $130000 per annum

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Randstad Digital

Madison, Wisconsin • Today

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AI Specialist / Trainer

Randstad Digital

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NOC Comms Specialist

Stellar Professionals LLC

Hybrid in Almont, Colorado • 2d ago

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Contract, Third Party

$22 - $24

Project Controls Specialist (Scheduler)-Hybrid

Generis TEK Inc.

Hybrid in Detroit, Michigan • 3d ago

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$50 - $55

IT Support Specialist

Ledgent Technology

Vancouver, Washington • Today

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Contract

$26.00 - $28.00 per hour

Growth Marketing Specialist (AI/Consumer Tech)

Pyramid Consulting, Inc.

Hybrid in San Francisco, California • 10d ago

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$80 - $85

Data Operations Specialist

Ledgent Technology

Corvallis, Oregon • Today

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Contract

$35 - $36 per hour

IT Lab Computing Support Specialist

TSR Consulting Services, Inc.

Washington • Today

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Contract

$38 - $48 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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