Study Start Up and Regulatory Affairs Specialist (2 years plus experience)

Full-time
Department: Study Start up and Regulatory Unit
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
Minimum 2years 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.
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.

1 Ergomed Plc jobs in England & Wales