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Precision for Medicine is a clinical research organization (CRO) that combines advanced technologies, scientific expertise, and operational scale to accelerate the development of life-changing therapies. The company specializes in oncology and rare disease clinical trials, integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
The Regulatory and Site Start-Up Specialist (RSS) is an experienced professional responsible for regulatory and site start-up activities across assigned countries. This role serves as a key liaison between regulatory authorities, ethics committees, clinical sites, and internal teams to ensure timely and compliant site activation.
Key responsibilities include:
- Preparing and submitting clinical trial applications and regulatory dossiers to Competent Authorities, Ethics Committees, and other local bodies in compliance with ICH-GCP and local regulations
- Managing interactions with regulatory and ethics authorities, including handling submissions and responses
- Developing and maintaining site activation readiness plans, project trackers, and regulatory intelligence tools
- Customizing and managing Informed Consent Forms and Patient Information Sheets for country-specific requirements
- Coordinating translation of regulatory documents
- Collecting, reviewing, and maintaining essential documents required for site activation and Investigational Medicinal Product (IMP) release
- Acting as a subject matter expert on local clinical trial regulations and providing guidance to internal teams (CRAs, Clinical Site Specialists, etc.)
- Supporting site contract negotiations and budget discussions under the direction of the Site Contract Management department
- Maintaining audit and inspection readiness through proper document filing in the Trial Master File
- Collaborating with feasibility, clinical operations, project management, and regulatory teams on country-specific deliverables
- Supporting pre-study site visits and process improvement initiatives as needed
The role requires strong organizational and communication skills, with the ability to prioritize workload and manage multiple regulatory pathways simultaneously across different jurisdictions.
Requirements:
- Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN) credential, or equivalent combination of education, training, and experience
- Minimum 1 year of experience as a Regulatory or Site Start-Up Specialist (or comparable role) in a CRO, pharmaceutical, or biotech industry
- Strong communication and organizational skills
- Proficiency with computerized information systems, electronic spreadsheets, word processing, and email
- Fluency in English; fluency in the local language of the country where the position is based is required for non-English speaking countries
Preferred qualifications:
- Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions) specific to the assigned country
- Experience with milestone tracking tools and systems
- Advanced degree in medical or life sciences (MD, PhD, PharmD)
- RAC (Regulatory Affairs Certification) or Master's degree in Regulatory Science
