Manager, Regulatory Registration and Compliance

Ergomed is seeking a Manager for Regulatory Registration and Compliance to lead complex regulatory projects and develop strategic frameworks. This role involves providing expert guidance to stakeholders, overseeing high-quality submissions to health authorities, and mentoring junior team members to ensure organizational excellence.

Key responsibilities

• Lead and coordinate complex regulatory projects, ensuring timely delivery and compliance with global requirements.
• Develop regulatory strategies, manage project setup activities, and provide expert guidance to internal and external stakeholders.
• Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other health authorities.
• Manage project resources, budgets, and team performance to meet agreed objectives.
• Support business development through proposal development and client engagements.

Requirements

• University degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology.
• Proven experience in the pharmaceutical or CRO sector, including leadership or project management roles.
• Strong knowledge of EU regulatory areas, ICH GCP/GVP, and global pharmaceutical requirements.
• Excellent organizational skills with the ability to manage multiple projects and deadlines.
• Advanced proficiency in English, both written and verbal.

What we offer

• The opportunity to contribute to bringing safe and effective treatments to patients globally.
• A collaborative and diverse work environment built on values of integrity, agility, and belonging.
• Professional growth opportunities within a global team of experts in clinical research and pharmacovigilance.
• A supportive culture that prioritizes patient safety and innovation.