ERGOMED
Specialist/Snr Specialist Study Start Up and Regulatory Affairs
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Company Description
Medicine moves forward here. So will you.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality, and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.
That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers, and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia, and Australia, we value teamwork, flexibility, and a real commitment to work-life balance, because good science comes from people who feel supported.
If you want work with purpose, the agility to make an impact, and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
Job Description
Senior Specialist, Study Start-Up and Regulatory Affairs
The Senior Specialist, Study Start-Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory compliance, and serves as a key liaison between internal teams, clients, and external stakeholders.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
- Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
- Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
- Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
- Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
- Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
- Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines.
- Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance, etc., to ensure compliance with ICH GCP & country-specific requirements.
- Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
- Arrange for and/or review translation of essential documents as required.
- Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures, and core documents.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardize deliverables; support corrective/preventive actions.
- Performs other work-related duties as assigned.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Qualifications
- Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience.
- Minimum 4 years within the pharmaceutical or CRO industry or Regulatory body.
- Good knowledge of ICH GCP and national regulations for territories of competency.
- Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas.
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills
Location