Regulatory Submissions & Contract Specialist (Dual Role)

About the role

Medpace is seeking a full‑time, home‑based Regulatory Submissions & Contract Specialist to join its Clinical Operations team in Latvia. The dual‑role position combines regulatory filing duties with contract negotiation support, offering hands‑on experience across clinical trial start‑up activities.

Key responsibilities

• Prepare, review and file initial clinical trial applications to Latvian regulatory authorities and Ethics Committees.
• Respond to queries, submit amendments and ensure all submissions meet current regulations and guidance.
• Maintain the Clinical Trial Management System and guarantee timely document filing.
• Collect essential documents and assemble drug‑release packages.
• Draft, review, negotiate and finalize study agreements, termination letters and other legal documents.
• Identify legal, financial and operational risks, escalating them to the Contract Lead or Manager.
• Provide negotiation recommendations and coordinate with internal functions to align site start‑up timelines with contractual processes.

Required profile

• Bachelor’s degree, preferably in Life Sciences or Law.
• Experience preparing and submitting regulatory documentation to Ethics Committees and regulatory agencies, including query responses.
• Background in a CRO, pharmaceutical company or investigative site.
• Strong knowledge of Latvian regulatory guidelines and legislation.
• Excellent organizational, prioritisation and independent work skills.
• Fluency in Latvian and English with high attention to detail.

Required skills

• Microsoft Office
• Clinical Trial Management System