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Clinical Regulatory Affairs Specialist - Small Molecule

Emergere Technologies

Remote • Today

Easy Apply

Contract

Depends on Experience

Regulatory Affairs Specialist

NexInfo Solutions, Inc.

Remote • 14d ago

Easy Apply

Third Party, Contract

$60 - $70

Regulatory Affairs Specialist

Pentangle Tech Services

Lake Forest, California • 16d ago

Easy Apply

Full-time, Third Party

Depends on Experience

Medical Device Regulatory Affairs Specialist

Synkriom

Warsaw, Indiana • 3d ago

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Contract

Depends on Experience

Regulatory Affairs Specialist 4

DGN Technologies

Sunnyvale, California • Today

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Third Party, Contract

$60 - $60

Regulatory Specialist

Trinite Consulting Group LLC

Remote • 7d ago

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Contract

Depends on Experience

Regulatory Affairs Specialist Small Molecule

Jean Martin, Inc

Remote • Today

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Third Party, Contract

Depends on Experience

Talent, Event & LIVE Security Specialist

First Tek, Inc.

New York, New York • 15d ago

Easy Apply

Full-time

Depends on Experience

Email Marketing Specialist at ort Washington, PA (3 days in Office, 2 days WFH)

Scalable Systems

Fort Washington, Pennsylvania • 7d ago

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Contract

Depends on Experience

Supervising Program Specialist

AgreeYa Solutions

Hybrid in San Leandro, California • 3d ago

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Third Party, Contract

$60 - $67

Profound Platform Specialist(Remote)

GSK Solutions Inc.

Remote • Today

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Contract, Third Party

Depends on Experience

Oncology Specialist 4721 & 4722

Randstad Digital

Remote or St. Louis, Missouri • Today

Contract

USD50 - USD55

Contracts & Program Specialist

Johnson Technology Systems Inc (JTSI)

Remote • 7d ago

Easy Apply

Full-time

$30 - $40

eDiscovery Specialist

Dexian DISYS

Chicago, Illinois • Today

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Full-time

$80000 - $120000 per annum

Project Coordinator / Specialist

Randstad Digital

New York, New York • Today

Contract

USD60 - USD66

Profound Platform Specialist

Stefanini

Remote or Dallas, Texas • Today

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Contract

$60 - $65 /hr

Technical Training Specialist

Rudra Enterprise LLC

Manor, Texas • Yesterday

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Full-time, Third Party

30 - 40

Digital Merchandising Specialist

Generis TEK Inc.

Bolingbrook, Illinois • Yesterday

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Contract

$18 - $21

AV Specialist

Dexian DISYS

Philadelphia, Pennsylvania • Today

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Contract

AWS Connect Specialist

V-Soft Consulting Group, Inc

Hybrid in Washington, District of Columbia • 17d ago

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Contract

Depends on Experience

Research Specialist - Credit

BCforward

Columbus, Ohio • Today

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Contract

$23.00 - $24.00 per hour

Marketing Specialist

BCforward

Minneapolis, Minnesota • Today

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Contract

$41.00 - $41.40 per hour

Assistant GIS Specialist

Randstad Digital

Kansas City, Missouri • Today

Contract

USD28 - USD30

Control Utility Team Specialist - Benefit Payments

BCforward

Newark, Delaware • Today

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Contract

$25.00 - $25.00 per hour

Telecom Escalations Specialist

STAND 8

Mountain View, Colorado • Today

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Contract

$18 - $28 per hour

Talent Acquisition Specialist

Dexian DISYS

Fairborn, Ohio • Today

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Contract

Red Team Specialist - Vulnerability Management / Manhattan NY / Mesa AZ - Hybrid

Svam International, Inc.

Hybrid in New York, New York • Today

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Contract, Third Party

Up to $70

IT Specialist II

Stefanini

Aurora, Colorado • Today

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Contract

$35 - $40 /hr

Materials Coordinator / Inventory Specialist

Strategic Staffing Solutions

Findlay, Ohio • Today

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Contract

USD22 - USD22

Junior Human Resources Specialist

Marici Solutions

Hybrid in Florham Park, New Jersey • Today

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Full-time

Depends on Experience

Job Details

Skills

Clinical Regulatory Affairs Specialist - Small Molecule

Summary

Job Title: Clinical Regulatory Affairs Specialist - Small Molecule

Location: Remote

Job Summary:

We are seeking an experienced Clinical Regulatory Affairs Specialist with a strong background in clinical regulatory affairs, Trial Master File (TMF) management, and small molecule drug development. The ideal candidate will have extensive experience supporting global clinical trials, preparing regulatory submissions, and ensuring compliance with FDA, EMA, Health Canada, and ICH guidelines. While familiarity with CMC regulatory activities is beneficial, this role is primarily focused on clinical regulatory operations and TMF management.

Key Responsibilities:

Lead and support clinical regulatory activities for small molecule development programs from early-phase through late-stage clinical trials.
Manage and maintain Trial Master Files (TMF/eTMF), ensuring inspection readiness and compliance throughout the clinical trial lifecycle.
Prepare, review, compile, and submit regulatory applications, including INDs, CTAs, NDAs, BLAs (where applicable), amendments, annual reports, and responses to Health Authority queries.
Coordinate global regulatory submissions and ensure timely delivery of required documentation.
Review clinical documents, including study protocols, Investigator''s Brochures (IB), informed consent forms (ICFs), Clinical Study Reports (CSRs), and safety documentation.
Ensure compliance with ICH-Google Cloud Platform, FDA, EMA, Health Canada, and other applicable global regulatory requirements.
Collaborate closely with Clinical Operations, Medical Writing, Clinical Development, Pharmacovigilance, Quality Assurance, Biostatistics, and Data Management teams.
Support regulatory inspections and audits by maintaining complete, accurate, and inspection-ready TMFs.
Track regulatory commitments, submission timelines, and health authority communications.
Contribute to regulatory strategies for global clinical development programs.

Required Qualifications:

Bachelor''s or Master''s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related discipline.
7–10+ years of experience in Clinical Regulatory Affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting small molecule clinical development programs.
Strong hands-on experience with Trial Master File (TMF/eTMF) management using platforms such as Veeva Vault TMF, DIA TMF, or equivalent systems.
Proven experience preparing and supporting IND, CTA, NDA, and other clinical regulatory submissions.
Thorough understanding of ICH-Google Cloud Platform, FDA, EMA, Health Canada, and global regulatory requirements.
Experience working with cross-functional clinical teams throughout the clinical development lifecycle.
Excellent project management, organizational, written, and verbal communication skills.
Ability to manage multiple priorities in a fast-paced, deadline-driven environment.

Preferred Qualifications:

Experience supporting global, multi-country clinical trials (Phase I–IV).
Experience interacting with Health Authorities and responding to regulatory questions.
Working knowledge of CMC regulatory activities for small molecule products is preferred.
Experience with electronic regulatory document management systems and Regulatory Information Management (RIM) tools.
RAC certification or other regulatory affairs certifications are considered an asset.
Preferred Skills

Clinical Regulatory Affairs:

Small Molecule Drug Development
Trial Master File (TMF/eTMF)
Veeva Vault TMF
IND, CTA, NDA Submissions
ICH-Google Cloud Platform Compliance
FDA, EMA, Health Canada Regulations
Clinical Trial Documentation
Regulatory Strategy
Inspection Readiness
Cross-Functional Collaboration
Clinical Operations

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: 91099596
Position Id: 9068163
Posted 2 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Contact the job poster

Sathish Kumar

Recruiter @ Emergere Technologies

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Description: Remote Our client is seeking an eTMF Specialist to support a biannual review of Phase Trial Master Files. The specialist will ensure TMFs are complete, accurate, compliant, and inspection-ready through comprehensive quality review and collaboration with internal and external stakeholders. Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefi

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Clinical Research Specialist

Remote or Irvine, California

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Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. This position is hybrid. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of ot

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Job Details

Skills

Clinical Regulatory Affairs Specialist - Small Molecule

Summary

Job Title: Clinical Regulatory Affairs Specialist - Small Molecule

Location: Remote

Job Summary:

Key Responsibilities:

Lead and support clinical regulatory activities for small molecule development programs from early-phase through late-stage clinical trials.
Manage and maintain Trial Master Files (TMF/eTMF), ensuring inspection readiness and compliance throughout the clinical trial lifecycle.
Prepare, review, compile, and submit regulatory applications, including INDs, CTAs, NDAs, BLAs (where applicable), amendments, annual reports, and responses to Health Authority queries.
Coordinate global regulatory submissions and ensure timely delivery of required documentation.
Review clinical documents, including study protocols, Investigator''s Brochures (IB), informed consent forms (ICFs), Clinical Study Reports (CSRs), and safety documentation.
Ensure compliance with ICH-Google Cloud Platform, FDA, EMA, Health Canada, and other applicable global regulatory requirements.
Collaborate closely with Clinical Operations, Medical Writing, Clinical Development, Pharmacovigilance, Quality Assurance, Biostatistics, and Data Management teams.
Support regulatory inspections and audits by maintaining complete, accurate, and inspection-ready TMFs.
Track regulatory commitments, submission timelines, and health authority communications.
Contribute to regulatory strategies for global clinical development programs.

Required Qualifications:

Bachelor''s or Master''s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related discipline.
7–10+ years of experience in Clinical Regulatory Affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting small molecule clinical development programs.
Strong hands-on experience with Trial Master File (TMF/eTMF) management using platforms such as Veeva Vault TMF, DIA TMF, or equivalent systems.
Proven experience preparing and supporting IND, CTA, NDA, and other clinical regulatory submissions.
Thorough understanding of ICH-Google Cloud Platform, FDA, EMA, Health Canada, and global regulatory requirements.
Experience working with cross-functional clinical teams throughout the clinical development lifecycle.
Excellent project management, organizational, written, and verbal communication skills.
Ability to manage multiple priorities in a fast-paced, deadline-driven environment.

Preferred Qualifications:

Experience supporting global, multi-country clinical trials (Phase I–IV).
Experience interacting with Health Authorities and responding to regulatory questions.
Working knowledge of CMC regulatory activities for small molecule products is preferred.
Experience with electronic regulatory document management systems and Regulatory Information Management (RIM) tools.
RAC certification or other regulatory affairs certifications are considered an asset.
Preferred Skills

Clinical Regulatory Affairs:

Small Molecule Drug Development
Trial Master File (TMF/eTMF)
Veeva Vault TMF
IND, CTA, NDA Submissions
ICH-Google Cloud Platform Compliance
FDA, EMA, Health Canada Regulations
Clinical Trial Documentation
Regulatory Strategy
Inspection Readiness
Cross-Functional Collaboration
Clinical Operations

Dice Id: 91099596
Position Id: 9068163
Posted 2 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Contact the job poster

Sathish Kumar

Recruiter @ Emergere Technologies

View Profile

Create job alert

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

Similar Jobs

Regulatory Specialist

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7d ago

Easy Apply

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Regulatory Affairs Specialist

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14d ago

Easy Apply

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eTMF Specialist, Pharma, BiAnnual Review Project

Remote or Almont, Colorado

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Today

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Clinical Research Specialist

Remote or Irvine, California

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Today

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