Regulatory and Site Start-Up Specialist

Precision For Medicine

. Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks .

Posted 9/21/2026full-timeRemote • South KoreaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws. Proficient in managing essential documents, project plans, and communication with regulatory bodies and project teams.

Highest-signal resume keywords

Regulatory SubmissionsSite Activation ReadinessClinical Trial Application PreparationProject ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ExperienceSite Start-Up SpecialistDocument ManagementMilestone TrackingClinical Trial Laws Knowledge

Soft Skills

Organizational SkillsCommunication SkillsPrioritization Skills

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic Mail

Certifications & Qualifications

Registered Nurse (RN)RAC CertificationAdvanced Degree in Medical or Life Sciences

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryEthics CommitteesIRBs

About the role

Key responsibilities & impact

Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks
Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
Interact with Competent Authorities and Ethics Committees and handle responses
Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
Maintain project plans, trackers, and regulatory intelligence tools
Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
Partner with site CRAs to align communication and secure site collaboration
Prepare, review, and manage essential documents for site activation and IMP release
Customize country/site-specific Patient Information Sheets and Informed Consent Forms
Facilitate document translations and coordinate translations required for submissions
Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
Act as subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews
Support study budget negotiations and investigator contract execution when required
Support feasibility activities and site outreach when needed
Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
Maintain audit/inspection readiness and file documents according to TMF and study-specific plans
Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring
Perform other duties assigned by management

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent combination of education, training, and experience
1 year or more as a Regulatory or Site Start-Up Specialist, or comparable role, in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
Strong communication and organizational skills
Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based
Relevant regulatory and site start-up experience for the particular country preferred
Experience using milestone tracking tools/systems preferred
Ability to prioritize workload to meet deadlines preferred
Advanced degree in medical or life sciences, MD, PhD, PharmD, RAC certification, or Master’s in Regulatory Science preferred

Benefits

Comp & perks

Regular full-time employment
Remote work arrangement
Equal opportunity employer
Reasonable accommodation for applicants with disabilities