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Regulatory affairs intern

Uxbridge
Internship
Posted: 2h ago
Offer description

Regulatory Affairs Intern We are excited to invite you to join our dynamic Regulatory Affairs team at Regeneron. As a Regulatory Affairs Intern, you will play a vital role in supporting the drug development process, from clinical studies to the approval of new drugs. This position offers a unique opportunity to collaborate with internal stakeholders and contribute meaningfully to the regulatory landscape. If you're eager to learn, grow, and make an impact in the pharmaceutical industry, this role is for you. A Typical Day: Provide hands-on support for the submission and tracking of clinical trial applications (CTAs), including national applications and submissions under clinical trial regulations. Assist in managing and maintaining approved CTAs, ensuring compliance with ICH GCP principles and regional equivalents. Collaborate with clinical study teams to guarantee appropriate regulatory support from CROs and other partners. Monitor and track changes in EU and UK legislation and guidelines to ensure Regeneron remains compliant. Ensure agency correspondence is properly filed and archived in line with company processes. Support agency interactions, such as scientific advice and national meetings. Contribute to emerging regulatory projects, workstreams, processes, or work instructions in collaboration with the Regulatory Submission Project Management (RSPM) team. Present a regulatory topic of interest to the European Regulatory Team, as agreed upon with your Line Manager. This Role May Be For You If: You enjoy working in a collaborative environment and value teamwork. You have a keen eye for detail and are committed to maintaining compliance with regulatory standards. You are proactive in tracking and adapting to evolving legislation and guidelines. You thrive in a role that combines operational tasks with strategic contributions. You are eager to learn and take on new challenges in a fast-evolving field like regulatory affairs. To Be Considered: To qualify for this role, candidates should have a strong interest in regulatory affairs and the drug development process. While specific educational or experiential qualifications are not explicitly listed, it is expected that candidates demonstrate a foundational understanding of clinical trial regulations and compliance principles. Familiarity with EU and UK regulatory frameworks is a plus. Candidates with a proactive attitude and strong organizational skills will excel in this role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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.S.-based 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.

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