Study Start Up and Regulatory Affairs Specialist

Ergomed Group; Kraków; Hybrid; PLN 120,000 - 180,000; Full time

Job summary

Ergomed Group in Kraków is seeking a Study Start Up and Regulatory Affairs Specialist to lead and coordinate activities ensuring site initiation readiness. The role provides regulatory expertise and serves as a key liaison between internal teams, clients, and external stakeholders.

You will manage regulatory submissions, translations, and essential documents to ensure ICH-GCP compliance across territories, and contribute to regulatory strategy and planning for multi-country studies.

Qualifications

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Previous experience within 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

Responsibilities

• Lead and coordinate all activities related to achieving site initiation readiness.
• Provide regulatory/SSU expertise and act as liaison between internal teams, clients, and external stakeholders.
• Lead preparation, review, and quality control of regulatory and SSU documentation (submissions, essential documents, translations).
• Draft, negotiate, finalize, and execute clinical site agreements and ancillary agreements at country/region level.
• Review all relevant documentation to ensure compliance with ICH GCP and country-specific requirements.

Skills

Regulatory knowledge

ICH GCP knowledge

Multi-country SSU delivery

Education

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience

Job description

Study Start Up and Regulatory Affairs Specialist

• Full-time
• Department: Study Start up and Regulatory Unit

Medicine moves forward here. So willyou.

Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,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, dataqualityand 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 theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

If you wantworkwith 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.

The 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

• Accountable for delivery of assigned study start-up and regulatory milestones within definedscope.
• Make independent decisions within assigned scope regarding regulatory processes anddocumentation approaches.
• Handles medium-complexity regulatory environments, including multi-country requirementswhere applicable.
• Leads study start-up and regulatory activities for assigned countries or projects of mediumcomplexity, ensuring delivery in line with timelines, quality standards, and regulatoryrequirements.
• Leads preparation, review, and quality control of regulatory and study start-updocumentation (including submissions, essential documents, and translations) to ensurecompleteness, 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 withproject 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/legaldocumentation.
• Arrange for and/or review translation of essential documents as required
• Provide regulatory/SSU strategic input to internal and external customers. Develop theregulatory strategy and the SSU Plan, joint operating procedures and core documents
• Promptly identify and escalation risk/potential risk to the project team which may jeopardisedeliverables; support corrective/preventive actions
• Performs other work-related duties as assigned.

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
• Previous experience within pharmaceutical or CRO industry orRegulatory body
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good understanding of specific country requirementspertaining to SSU/Regulatory delivery in multiple countrieswithin Europe and/or the Americas

When you joinErgomedGroup, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin 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 theoutcome, becausesomeone is waitingonit.
• Agility and responsiveness:we movequickly, becausepatients 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.