Regulatory and Site Start Up Specialist

Precision For Medicine

Regulatory and Start Up Specialist at Precision for Medicine responsible for site activation in clinical trials. Ensuring compliance with regulatory requirements and providing project updates.

Posted 7/21/2026full-timeRemote • 🇹🇼 TaiwanJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, including Clinical Trial Application Forms and communication with Competent Authorities and Ethics Committees. Proficient in project management and coordination of site activation processes within the clinical trial landscape.

Highest-signal resume keywords

Regulatory SubmissionsClinical Trial Application PreparationProject ManagementCommunication SkillsFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory IntelligenceClinical Trial Application FormsStudy Specific Start-Up PlansEssential Document ReviewPatient Information Sheet CustomizationInformed Consent Form CustomizationSite Activation Data ManagementBudget Negotiation SupportInvestigator Contract ExecutionPharmacy Qualification

Soft Skills

Strong Communication SkillsOrganizational Skills

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord ProcessingElectronic Mail

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryLife SciencesHealthcare Discipline

About the role

Key responsibilities & impact

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites
Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies
Interaction with CA/EC for study purposes and handling responses to the CA/EC.
Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities
Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
Customize country/site specific Patient Information Sheet and Informed Consent Form.
Responsible for/facilitates the translation and co-ordination of translations for documents.
Maintain communication with other key functions participating to country start up.
Act as SME for collection and maintenance of site level critical path to Site Activation data points,
May participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
May support the clinical team performing Pre-Study Site Visits.

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline)
A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
1 year or more as a Regulatory or SU specialist (or comparable role) in either 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 required.
Fluency in English.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options