RemoteLeaf Logo
Log in Sign up

Regulatory and Site Start Up Specialist

1 hour, 54 minutes ago
Taiwan
Full-time
Junior
Compliance Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 73

Description

  • Own timely, high-quality site activation readiness for assigned countries and sites, while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers, including initial submissions and amendments/notifications, for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage interactions with Competent Authorities and Ethics Committees and respond to their questions or requests.
  • Provide regular status updates on regulatory and ethics submissions to study leadership, project managers, and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure collection of essential documents for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate and facilitate document translations as needed.
  • Act as a subject matter expert on local site activation critical path items, including authority timelines, contract and budget requirements, and other review steps.
  • Support study budget negotiations and investigator contract execution when required.
  • Maintain audit and inspection readiness and file documents according to TMF plans and study-specific requirements.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or Registered Nurse (RN), or an equivalent combination of education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start Up Specialist, or in a comparable role, within a CRO, pharmaceutical, or biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload and meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Opportunity to work on ground-breaking cancer therapies and other precision medicine studies.
  • A growing organization where employee contributions are recognized and valued.
  • The chance to provide input, have ideas heard, and influence positive change.
  • Equal Opportunity Employer status with non-discriminatory employment practices.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Alphasense

Compliance Analyst

Alphasense 51-250 Industrial Conglomerates

AlphaSense is hiring a Compliance Analyst for its India Compliance Review team to support 24x5 global review coverage and help protect clients by reviewing expert call transcripts for sensitive information.

India Junior Compliance Manager
9 minutes ago
Olsson

Group Leader - Roadway

Olsson 1K-5K Construction & Engineering

Olsson is hiring a Group Leader to lead a transportation design team delivering highway and roadway projects while maintaining active client, project, and business development involvement.

United States Full-time Lead Operations Manager Project Manager
24 minutes ago
Olsson

Lead Project Manager - Data Center

Olsson 1K-5K Construction & Engineering

Olsson is seeking an experienced Project Manager to lead complex, multidisciplinary data center projects from development through delivery, ensuring they are completed on time, within scope, and on budget.

United States Full-time Lead Project Manager
39 minutes ago
Precision Medicine Group

Regulatory and Start Up Specialist

Precision Medicine Group 251-1K Pharmaceuticals

Precision for Medicine is hiring a Regulatory and Start Up Specialist to support clinical trial site activation and regulatory submissions across assigned countries and sites.

Hungary Full-time Junior Compliance Manager Program Manager
39 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers