Senior Specialist Study Start Up & Regulatory Affairs

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. 

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.       

ROLE AND RESPONSIBILITIES

• 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.
• May collaborate with internal and external legal, finance and clinical operations department including communicating and explaining legal and budgetary issues in relation to countries of assignment.
• Responsible for site outreach in assigned country/countries; point of contact for site, sharingof non-confidential and confidential study information and management of confidential disclosure agreements.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation readiness.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 jeopardise deliverables; support corrective/preventive actions
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Provide expert advice to Clients addressing complex regulatory queries and liaison with authorities
• Acts as country or regional subject matter expert for all regulatory and CSA elements on assigned studies for internal and sponsor stakeholders alike and ensures country intelligence is up to date in country intelligence repositories and any changes promptly disseminated
• Ensure timely and accurate completion of project trackers, correspondence log filing in study portal and TMF, and QC of submission dossiers
• Provide support to BD proposal development and input to budgets, provide department representation to BD meetings as required.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide input to department / company initiatives and contribute to the design/review of
• SOPs/working practice/guidance.
• Provide training, coaching and mentoring to junior members of staff.
• Performs other work-related duties as assigned.

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
• Previous experience within the pharmaceutical/CRO industry 
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good written and verbal communication skills to clearly and concisely present information
• Proficiency in English, both written and verbal 
• Excellent planning and organizational skills
• Strong planning, strategizing, managing, monitoring,
  scheduling, problem-solving and critiquing skills Excellent
  ability to manage multiple tasks, set priorities, and adapt to
  changing work assignments
• Ability to exercise sound judgment and make decisions
  independently
• Effective written and verbal communication skills to clearly
  and concisely present information
• Remarkable attention to details
• Excellent self-motivation and motivation skills

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.