Senior Regulatory and Start-up Specialist

TL;DR

Senior Regulatory and Start-up Specialist: Lead ethics and regulatory submissions and drive study start-up activities for global clinical trials with an accent on GCP/ICH compliance, submission strategy, and inspection-ready documentation. Focus on coordinating timelines and quality across assigned countries while supporting site contracts and budgets and resolving regulatory start-up challenges.

Location: home-based, anywhere in Romania (Bucharest, Romania)

Company

hirify.global is a mid-sized full-service CRO delivering new therapies across Europe and North America.

What you will do

• Lead and coordinate ethics and regulatory submissions across assigned countries, owning timelines, quality, and compliance.
• Prepare, review, and submit clinical trial applications and regulatory documentation to ethics committees and health authorities.
• Act as a key point of contact for clients and project teams during the study start-up phase.
• Plan and drive submission strategies, timelines, and start-up activities to ensure efficient study initiation.
• Collaborate with Project Management, Clinical Operations, and Quality to support smooth study set-up.
• Support site contract and budget activities, including review, negotiation support, and coordination.

Requirements

• Degree in life sciences (e.g., pharmacy, biology, medicine, or similar).
• 4+ years of experience in regulatory and start-up activities within a CRO or pharmaceutical environment.
• Strong knowledge of GCP, ICH guidelines, and regulatory submission requirements.
• Solid understanding of clinical trial processes and the drug development lifecycle.
• Experience with site contracts and budgets, ideally with some involvement in negotiations.
• Home-based in Romania; fluent English (written and spoken).

Culture & Benefits

• Home-based role with flexible work hours.
• Performance and referral bonuses.
• Training and development program plus employee engagement and well-being initiatives.
• International projects and professional growth within a clinical research team.

Hiring process

• Submit a CV; only shortlisted candidates are contacted for further selection.
• Final offer reflects experience, skills, and qualifications.