(Senior) Specialist Regulatory Affairs/Start-up

👋 About Ergomed Group:

Ergomed Group is a thriving, mid-sized CRO specializing in Oncology and Rare Diseases. Since 1997, we've grown steadily through strategic investments and acquisitions, establishing a global presence in Europe, North America, and Asia. We foster a collaborative, international culture that values employee well-being and a healthy work-life balance. We believe in providing opportunities for growth and development, and we encourage our employees to contribute creatively. Join us in making a positive impact on patients' lives!

🚀 The Role:

As a Senior Specialist in Regulatory Affairs and Study Start-Up, you'll play a key role in ensuring the timely and compliant initiation of clinical trials. You will work closely with various teams, authorities, and vendors to manage regulatory submissions and documentation.

What You'll Do:

• 🎯 Support Study Start-Up: Collaborate with the SSU/Regulatory Lead to establish and maintain project timelines, proactively identifying and resolving issues. Develop contingency plans to address potential delays.
• 📄 Regulatory Submissions: Prepare, review, and submit regulatory documents (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) to relevant authorities (FDA, EMA, national agencies) and Ethics Committees/IRBs.
• 🗂️ Document Management: Collect, review, and track essential documents for efficient site initiation and activation. Investigate and resolve any inconsistencies or missing information. Prepare status reports for the study team.
• 🤝 Site Communication: Maintain regular communication with investigative sites regarding document completion, ICF development, and regulatory submissions/approvals.
• ✍️ ICF Development: Participate in the development, review, negotiation, and approval of Informed Consent Forms.
• 🤝 Cross-Functional Collaboration: Coordinate with various teams (study teams, sponsors, clinical monitoring, clinical contracts) to prioritize and process documents for investigational product release and site activation.
• 🗺️ Site Support: Contribute to feasibility studies, site identification, and site document customization.
• 🗣️ Translation: Arrange for and/or review the translation of essential documents as needed.
• 🗄️ Trial Master File (TMF): Ensure timely submission of all relevant documents to the TMF, adhering to SOPs and study-specific requirements.

💪 What We're Looking For:

• 🎓 Education: Bachelor's degree in a science-related field (or equivalent experience).
• 💼 Experience: Experience in the pharmaceutical, biotechnology, or CRO industry, with a strong understanding of clinical trials. Proven experience in clinical trial regulatory submissions is essential.
• 🗣️ Communication: Excellent written and verbal communication skills.
• 🤝 Interpersonal Skills: Strong interpersonal and organizational skills, with meticulous attention to detail.
• 💡 Problem-Solving: Proactive problem-solving skills and the ability to manage client relationships effectively.
• 🔬 Clinical Research Knowledge: Understanding of clinical research principles, methods, and procedures.
• 💻 Technical Skills: Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• ➕ Preferred Qualifications: Experience with ICH/GCP documentation and processes. Ability to manage multiple projects simultaneously, prioritizing tasks effectively.

🌟 Benefits & Perks:

• 📈 Career Development: Excellent opportunities for professional growth and development within a global organization.
• 🤝 Supportive Environment: Friendly and supportive working environment.
• 🌍 Global Collaboration: Opportunity to work with colleagues worldwide, with English as the company language.
• 🌱 Personal Growth: Strong emphasis on personal and professional development.

Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—guide our work. If these resonate with you, Ergomed is the place to be!