Clinical Submissions Manager

1 month ago

Dublin, Ireland Regeneron Ireland DAC Full time

The Clinical Submission Manager will have responsibility for planning and delivery of European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role. The position requires a subject matter authority in Clinical Trial Application (CTA) in EU countries, partnering with EU countries on their local site strategy allocation. In this role, a typical day might include: Engage with Regulatory Affairs and Clinical Trial Management to plan Clinical Trial Applications (CTA) and determine key study achievements and country allocation strategies. Ensure trials align with national regulatory requirements, strategize submissions for timely approvals, and archive all trial-related documents in compliance with regulations and company policies. Identify and capture key study achievements, participating countries, institutions, and primary investigators in the CTIS database, and manage this information throughout the study lifecycle. Implement risk management strategies to mitigate potential issues impacting Part II activities and prioritise any questions or requests for information related to clinical trial applications. Oversee vendors involved in collecting and maintaining CTA information, and coordinate with local ethics committees for approvals and addressing concerns. Supervise and report on the progress of Part II activities, ensuring alignment with trial timelines and objectives, and stay updated on regulatory changes and industry standard methodologies to improve processes. This role might be for you if: You have an innate understanding of the clinical drug development process, ICH/GCP, and regulatory guidelines/directives. You are fully proficient on EUCTD/R and the Federal Code of Regulations. You should be familiar with using Veeva Vault Clinical for CTMS and eTMF. You are at ease with effective problem-solving and decision-making skills. You posses strong interpersonal, collaboration, and stakeholder management skills, along with good written and verbal communication abilities. To be considered, you must have a Bachelor's degree in a related field with at least five years of functional experience in Pharma/Biotech/CRO industry. 7+ years' of relevant experience, and a minimum of 1-3 years' experience of clinical submission experience. An innate ability to prioritize and run multiple projects simultaneously. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

  • Manager, Regulatory Submission Project Management

    4 months ago

    Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

    SUMMARY: The Manager, Regulatory Submission Project Management will be responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to postmarketing. The incumbent will report to the Sr Mgr Regulatory Submission Project Management and serve as the Reg PM lead for assigned therapeutic area (TA) and...

  • Clinical System Lead

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Clinical System Lead - Office based, Swansea or Dublin ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical System...

  • Vice President, Global Regulatory Affairs Consulting Services

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    VP, Global Regulatory Affairs Consulting Services/ Ireland ,UK, Spain, Poland / Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an...

  • Associate Clinical Data Science Programmer

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Associate Clinical Data Science Programmer - Office -based, Swansea or Dublin ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Associate Clinical...

  • Senior Quality Officer

    3 months ago

    Dublin, Ireland Eurofins Ireland Clinical Diagnostics Full time

    Job DescriptionThe successful candidate will be responsible for maintaining the Quality Management System. Building relationships with our Heads of Departments, and colleagues in Eurofins Biomnis, Eurofins Pathology and Eurofins Lablink. Ensuring, in conjunction with the Quality team, that the laboratory and Logistics division operates within the...

  • Manager, Scientific Affairs

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Manager, Scientific Affairs ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. This is an exciting opportunity to work within a fast paced, busy...

  • Clinical Perfusion Scientist

    3 weeks ago

    Dublin, Ireland Children's Health Ireland Full time

    Clinical Perfusion Scientist The purpose of this post is to set up and operate equipment under the direction of the Cardiac Surgeon(s) for the provision of total or partial circulatory/respiratory support during surgery and carry out various extracorporeal techniques/procedures during surgery or in other situations where deemed necessary. Essential Criteria:...

  • Clinical Nurse Manager II

    4 weeks ago

    Dublin, Ireland Children's Health Ireland Full time

    Purpose of the Role: The Clinical Nurse Manager II has a pivotal role in supporting the CNM III in the co-ordination, strategic planning and management of nursing activities and staff resources within the Emergency department at CHI Crumlin. The post holder will work within a risk management framework to achieve HIQA Safer Better Healthcare standards. The...

  • Manager, Regulatory Affairs CMC

    4 months ago

    Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

    We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. In this role, a typical day might include the following: Contributes to the management of the regulatory submission form process,...

  • Clinical Nurse Education Facilitator Surgical Flat

    4 weeks ago

    Dublin, Ireland Children's Health Ireland Full time

    Purpose of the Role: The post holder Clinical Educator Facilitator (CEF) will work as part of the Surgical Flat and Day ward team to manage the clinical educational needs of staff and students within the ward. The CEF is based primarily in clinical practice, supernumerary to the clinical nursing team, to focus solely on the ward / unit educational and...

  • Medical Writing Manager

    4 months ago

    Dublin, Ireland Gilead Sciences Ireland UC Full time

    Description   Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening...

  • Senior or Principal Biostatistician

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Senior or Principal Biostatistician - EMEA ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Senior or Principal Biostatistician EMEA, Homebased We...

  • Associate Project Manager

    1 month ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Associate Project Manager - Ireland, Dublin Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. ICON plc is a world-leading healthcare...

  • Associate Project Manager

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Associate Project Manager - Ireland, Dublin Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. ICON plc is a world-leading healthcare...

  • Financial Business Partnering Analyst

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Financial Analyst - Business Partnering - Dublin 18 - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. With our patients at the centre of all...

  • Director, Project Management

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Director, Project Management ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. ICON plc is a world-leading healthcare intelligence and clinical...

  • VP, Biometrics

    3 weeks ago

    Dublin, Ireland ICON Clinical Research Ltd Full time

    VP, Biometrics Strategic Services, Ireland/ UK, Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Vice President of Biometrics is a dynamic...

  • Quality and Clinical Risk Manager

    1 month ago

    Dublin, Ireland Blackrock Health Full time

    Job Title: Quality and Clinical Risk Manager Department: Quality Department Job Type: Specified Purpose Contract - 12 months Hours: 37 per week (Full-Time) Blackrock Clinic is the leading and longest established private hospital and clinic in Ireland. Since it opened in the mid-1980s, the clinic has consistently built an unparalleled reputation in new...

  • Financial Business Partnering Analyst

    4 weeks ago

    Dublin, Ireland ICON Clinical Research Limited Full time

    Financial Analyst - Business Partnering - Dublin 18 - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. With our patients at the centre of all...

  • Clinical Nurse Manager

    1 month ago

    Dublin, Ireland recruitNet Full time

    RecruitNet International Ltd is specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through professional registration, job placement, visa, and employment permit processing.We will provide exceptional patient care in an environment where quality, respect, caring, and compassion are at the center of all we do.We...