Job Description
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.