Regulatory Associate II

Tolmar Careers•Windsor, CO

1d•Hybrid

About The Position

Under supervision, this role assists in all functions pertaining to domestic and international regulatory submissions, including the preparation of documents for electronic or paper filing for drug projects. This involves working on project teams to guide development to meet regulatory registration requirements.

Requirements

Proficient knowledge of word processing, specifically MS Office Suite, and Adobe Reader/Writer.
Knowledge of Database Management software.
Excellent writing and organizational skills.
Ability to coordinate information from various 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 suitable for inclusion in regulatory submissions.
Ability to understand, and comply with domestic and international regulatory requirements.
Ability to follow specific directions and to request instructions for complex tasks.
Bachelor’s degree required, preferred in a scientific field.
Two or more years’ in regulatory or four years’ applicable pharmaceutical industry experience with knowledge and experience in preparing and submitting regulatory dossiers/applications to regulatory agencies.

Responsibilities

Represent and serve as regulatory representative in project team meetings with consultation.
Offer regulatory opinions with consultation from regulatory management.
Assist regulatory management and team with tracking and driving timelines.
Review and approve all controlled documents with minimal mentorship.
Create and review routine submission documentation with minimal mentorship.
Coordinate with personnel from other departments to obtain data/documentation for submissions with guidance from the manager.
Review new and existing procedures with mentorship.
Keep current with global health authority regulations/guidelines.
Conform to regulatory department standards and compliance with GMP.
Perform various other duties as assigned.