Manager, Regulatory Registration and Compliance

📋 Description

• Lead and coordinate complex regulatory projects, ensuring timely, high-quality delivery and
• Develop regulatory strategies, manage project setup activities, and provide expert guidance to
• Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other
• Identify and mitigate risks, resolve project issues, and ensure adherence to company processes and
• Manage project resources, budgets, and team performance to meet agreed timelines and objectives.
• Support business development through proposal development, budgeting, and client engagements.

🎯 Requirements

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
• Experience in the pharmaceutical, CRO, or regulatory sector, including experience in a leadership
• Knowledge of Regulatory (EU) area and applicable legal and other requirements, both local and
• Excellent organizational skills with the ability to manage multiple projects and deadlines.
• A collaborative mindset, coupled with excellent communication skills to liaise with clients and
• Advanced knowledge of English (both written and verbal)

🎁 Benefits

• When you join Ergomed Group, you make a difference by helping to bring safe and effective
• You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance
• We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a