Regulatory Associate II, CMC DEV

Tolmar

. Assist with domestic and international regulatory submissions for drug projects .

Posted 10/7/2026full-timeWindsor • Colorado • United StatesJuniorMid-Level💰 $90,000 - $105,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions for drug projects, with a strong understanding of domestic and international regulatory requirements. Proficient in preparing regulatory dossiers and coordinating cross-departmental information to ensure compliance with health authority regulations.

Highest-signal resume keywords

Regulatory SubmissionsRegulatory Dossiers PreparationMS Office Suite ProficiencyExcellent Writing SkillsKnowledge of GMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Dossiers PreparationDatabase Management SoftwareDocument Review and ApprovalProject Timeline Tracking

Soft Skills

Excellent Writing SkillsOrganizational SkillsAbility to Coordinate InformationAbility to Perform Multiple TasksAbility to Follow Directions

Tools & Technologies

MS Office SuiteAdobe ReaderAdobe Writer

Industry Keywords

Regulatory AffairsPharmaceutical IndustryGlobal Health Authority RegulationsGMP ComplianceRegulatory Requirements

About the role

Key responsibilities & impact

Assist with domestic and international regulatory submissions for drug projects
Prepare documents for electronic or paper filing
Participate on project teams to guide development toward regulatory registration requirements
Represent regulatory affairs in project team meetings with consultation
Provide regulatory opinions with consultation from regulatory management
Track and drive project timelines
Review and approve controlled documents with minimal mentorship
Create and review routine submission documentation
Coordinate with other departments to obtain submission data and documentation
Review procedures with mentorship
Maintain current knowledge of global health authority regulations and guidelines
Comply with regulatory department standards and GMP
Perform other assigned duties

Requirements

What you’ll need

Bachelor’s degree required, preferably in a scientific field
Two or more years in regulatory or four years of applicable pharmaceutical industry experience
Knowledge and experience preparing and submitting regulatory dossiers/applications to regulatory agencies
Proficient knowledge of MS Office Suite and Adobe Reader/Writer
Knowledge of database management software
Excellent writing and organizational skills
Ability to coordinate information from internal and external disciplines
Ability to understand regulatory and technical concepts and requirements
Ability to perform multiple tasks on several projects
Ability to prepare written summaries of technical data for regulatory submissions
Ability to understand and comply with domestic and international regulatory requirements
Ability to follow specific directions and request instructions for complex tasks
Ability to work in a normal office environment and/or remotely from a home office

Benefits

Comp & perks

Strong benefits package
Equitable, fair pay practices
Remote work from home office
Some travel may be required