Global Site Activation & Regulatory Specialist

Precision Medicine Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to drive site activation readiness and regulatory submissions across assigned countries. You will manage CTAs, submissions to authorities, and EC interactions, while coordinating with operations, clinical and regulatory teams to ensure timelines are met.

Ideal candidates bring a life sciences degree (RN/PharmD beneficial) and 1+ year in regulatory/start-up roles, with excellent English communication and strong

Qualifications

• Bachelor's degree in life sciences or related field; RN or PharmD is beneficial.
• 1+ year as Regulatory or Start-Up specialist (or similar) in CRO or pharma.
• Fluency in English with strong communication and organizational skills.

Responsibilities

• Deliver site activation readiness for assigned country/sites on time and with quality.
• Prepare Clinical Trial Applications and submission dossiers for authorities and ethics committees.
• Interact with CA/EC and manage responses; provide updates to regulatory leads and project team.
• Maintain project plans, trackers and regulatory intelligence tools; support start-up plans.
• Coordinate translations and collection of essential documents for site activation/IMP release.
• Collaborate with site CRAs and cross-functional teams to ensure alignment and timely deliverables.
• Maintain TMF readiness and support audit/inspection readiness; assist Pre-Study Site Visits.

Skills

Regulatory start-up

Communication skills

Organizational skills

Project coordination

English fluency

Education

Bachelor's degree in life sciences

RN or PharmD beneficial

Regulatory/Start-up experience (1+ year)

Job description

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to drive site activation readiness and regulatory submissions across assigned countries. You will manage CTAs, submissions to authorities, and EC interactions, while coordinating with operations, clinical and regulatory teams to ensure timelines are met.

Ideal candidates bring a life sciences degree (RN/PharmD beneficial) and 1+ year in regulatory/start-up roles, with excellent English communication and strong