RemoteLeaf Logo
Log in Sign up

Regulatory and Site Start Up Specialist

3 days, 13 hours ago
China
Full-time
Junior
Compliance Manager
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 132

Description

  • Prepare clinical trial application forms and submission dossiers for initial submissions and amendments/notifications to competent authorities, ethics committees, and other local bodies.
  • Interact with competent authorities and ethics committees for study-related submissions and responses.
  • Track and report the status of regulatory and ethics submissions to study leadership, project managers, and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Develop and support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Work with site CRAs to align communication and support site collaboration during start-up.
  • Prepare, review, and collect essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for local country and site requirements.
  • Coordinate document translations needed for submissions and site start-up.
  • Coordinate with feasibility, clinical operations, project management, regulatory, and site contracts teams on project status and deliverables.
  • Act as a subject matter expert on site activation timelines, local reviews, site contracts, and budget negotiation requirements.
  • Support budget negotiations and investigator contract execution when required.
  • Maintain knowledge of local clinical trial laws and regulations and share updates internally to support compliant trial conduct.
  • Maintain audit and inspection readiness and file documents according to TMF plans and study-specific requirements.
  • Support pre-study site visits, process improvement initiatives, training, and mentoring as needed.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or RN, or an equivalent combination of education, training, and experience.
  • At least 1 year of experience in a Regulatory or Site Start Up specialist role, or a comparable role, in CRO or pharmaceutical/biotech settings.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • 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 specific country, including feasibility, contract negotiations, and CA/EC/IRB submissions, preferred.
  • Experience using milestone tracking tools or systems, preferred.
  • Ability to prioritize workload and meet deadlines, preferred.
  • Advanced degree in medical or life sciences such as MD, PhD, or PharmD, RAC certification, or a Master’s in Regulatory Science, preferred.

Benefits

  • Precision for Medicine offers a role based in Shanghai or Beijing.
  • Equal Opportunity Employer status with employment decisions made without regard to protected characteristics.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy policy and CA privacy notice provided for applicant data handling.
  • A formal recruiting and interview process is used before any job offer is made.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Coinbase

Regulatory Policy, Senior Associate

Coinbase 1K-5K Capital Markets

Coinbase is hiring a Regulatory Policy Senior Associate to support regulatory advocacy and policy development for its crypto and blockchain business in a fast-paced, remote-first-but-not-remote-only environment.

United States Full-time Senior Compliance Manager
$131k-$154k
Blockchain Generative AI Machine Learning
2 days, 23 hours ago
Remote

Payroll Risk & Compliance Principal - Nordics

Remote 251-1K Professional Services

Remote is hiring a Nordics Risk & Compliance Expert to own payroll compliance across Norway, Sweden, Denmark, and Finland, with formal statutory responsibility in Norway and a focus on embedding regional compliance into its global payroll platform.

Norway Full-time Lead Compliance Manager Payroll Specialist
$2k-$6k
2 days, 23 hours ago
Moniepoint

Data Protection Officer

Moniepoint 1K-5K Diversified Financial Services

Moniepoint is seeking a Data Privacy & Protection Officer to support its Compliance Team in managing privacy governance, regulatory compliance, and data subject rights across its financial operations in line with Nigerian and international data protection rules.

Nigeria Full-time Senior Compliance Manager
Cybersecurity Encryption
2 days, 23 hours ago
HelloFresh

[HELLOCONNECT] Sr. Sourcing & Contract Management Coordinator

HelloFresh 10K-50K Hotels, Restaurants & Leisure

HelloConnect is hiring a Strategic Procurement support professional to handle Source-to-Contract preparation, tender administration, and contract lifecycle tasks in Workday Sourcing and Icertis so category managers can run sourcing events efficiently and compliantly.

Philippines Full-time Mid Level Contract Manager
2 days, 23 hours 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