Impactful Study Start-Up & Regulatory Affairs Specialist

Ergomed; Województwo małopolskie; On-site; PLN 180,000 - 240,000; Full time

Job summary

Ergomed Group is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities related to site initiation readiness. The role provides subject matter expertise, ensures regulatory compliance, and acts as a key liaison between internal teams, clients, and external stakeholders.

The candidate will draft, review, and quality-control regulatory documents, manage translations, and support SSA activities across Europe and/or the Americas, ensuring timelines and

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Minimum 2years within pharmaceutical or CRO industry or Regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency.
• Good understanding of country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas.

Responsibilities

• Lead and coordinate all activities related to achieving site initiation readiness.
• Provide regulatory/SSU strategic input and develop regulatory strategy and plans.
• Draft, negotiate, finalize, and execute site agreements and amendments.
• Review documentation for compliance with ICH-GCP and country requirements.
• Manage translations of essential documents and liaise with clients and sites.

Skills

ICH-GCP

Regulatory knowledge

SSU delivery

CRO experience

Education

Graduate degree

Life Sciences background

Job description

Ergomed Group is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities related to site initiation readiness. The role provides subject matter expertise, ensures regulatory compliance, and acts as a key liaison between internal teams, clients, and external stakeholders.

The candidate will draft, review, and quality-control regulatory documents, manage translations, and support SSA activities across Europe and/or the Americas, ensuring timelines and