Manager, Start-up and Regulatory Affairs - Remote

Overview

The Manager, Study Start Up and Regulatory is responsible for developing the strategy based on regulatory requirements and for completing study start-up and regulatory deliverables.

In Short

• Lead and manage study start-up and regulatory tasks.
• Develop strategy and manage set up activities.
• Provide strategic input and address risks promptly.
• Ensure compliance with regulatory submissions to FDA, EMA, and others.
• Oversee project SSU deliverables from site selection to activation.
• Manage integrated site start-up timelines and weekly progress reports.
• Provide expert advice on complex SSU/regulatory queries.
• Review project budgets and scope of work with project PM.
• Foster relationships with internal and external contacts.
• Support client qualification activities and ensure audit readiness.

Requirements

• Degree in Chemistry, Life Sciences, Nursing, or equivalent.
• Minimum 3 years in pharmaceutical or CRO industry.
• Expert knowledge of ICH GCP and relevant regulations.
• Excellent organizational and management skills.
• Strong planning, problem-solving, and communication skills.
• Attention to detail and ability to manage multiple tasks.
• Proficiency in English, both written and verbal.
• Proficient in MS Office (Word, Excel, PowerPoint).

Benefits

• Competitive salary.
• Training and career development opportunities.
• Friendly, supportive working environment.
• Opportunity to work with colleagues globally.