Strategic SSU & Regulatory Affairs Specialist

Oncology Voice Network LLC; Northern (KY); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs to coordinate site initiation readiness and ensure regulatory compliance across multiple countries. You will serve as a key liaison between internal teams, clients, and external stakeholders, delivering regulatory milestones within defined timelines.

The role requires a graduate degree in a life sciences field and at least two years in pharma/CRO, with strong knowledge of ICH GCP and country-specific SSU requirements across

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent.
• Minimum 2 years in pharmaceutical/CRO or regulatory bodies.
• Strong knowledge of ICH GCP and national regulations.
• Experience with SSU/Regulatory delivery across Europe and the Americas.

Responsibilities

• Lead study start-up and regulatory activities for assigned countries or projects.
• Prepare, review, and quality-control regulatory documents and submissions.
• Draft and negotiate clinical site and ancillary agreements as needed.
• Identify risks to timelines and implement corrective actions.
• Act as liaison between internal teams, clients, and external stakeholders.

Skills

Regulatory affairs

SSU planning

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Chemistry / Life Sciences / Nursing

Job description

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs to coordinate site initiation readiness and ensure regulatory compliance across multiple countries. You will serve as a key liaison between internal teams, clients, and external stakeholders, delivering regulatory milestones within defined timelines.

The role requires a graduate degree in a life sciences field and at least two years in pharma/CRO, with strong knowledge of ICH GCP and country-specific SSU requirements across