Job Description
Who We Are: Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do: Theradex is recruiting for Head of Regulatory Affairs, Permanent, Full time homebased postion either in UK, Sweden, Denmark or Netherlands with 10 years experience to join our team. If you are passionate about regulatory affairs and want to be part of a dedicated oncology team, this opportunity may be for you. As the Head of Regulatory Affairs, you will be measured against the following objectives: Deliver a robust regulatory strategy, tactical planning, and execution that ensures timely approvals and lifecycle management aligned with business goals. Maintain full regulatory compliance and inspection readiness, ensuring adherence to all relevant regulatory standards and frameworks. Line Manager responsibility is to build and develop a high-performing Regulatory Affairs team while strengthening stakeholder engagement and influence. Your duties and responsibilities will include, but are not limited to, the following: Provide regulatory input for all assigned projects. Planning, preparation, and submissions of CTAs and country ICFs in EU/EEA and UK Prepare presentations and represent the department at Kick Off Meetings with clients. Tracks, reports and files CTA and modification submissions / approval progress in electronic trial master files (eTMF) and other applicable systems. Proactively provides tactical direction to the client on regulatory specific issues and provides associated mitigation as required. Participates in the quality control (QC) steps involved for all the above. Serves as key regulatory liaison for multi-continental project on behalf of Theradex Oncology (Europe). Liaison with other departments within Theradex, including Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution. Including the management of timelines to complete regulatory submissions on time Providing input into the scientific writing of several medical writing activities such as IMPDs, DSURs, study protocols, IBs and master patient information sheets Validate and provide input into our clients’ regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required Prepare client proposals and participate in bid defense meetings. Maintains awareness of the literature on cancer therapy, clinical trial design and conduct Knowledge of Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by Ethic Committees and Competent Authorities Provides regulatory training to other members of the team as required. What You Need: These are the skills and experience you will need to succeed as the Head of Regulatory Affairs: Minimum bachelor’s degree in a life science field or equivalent e.g. Pharmacy, Biology, Chemistry. Prior experience in Regulatory Affairs within the life sciences industry, including leadership /Line Management responsibility. Minimum of 10 years of experience in a regulatory role within the pharmaceutical industry, regulatory agency or CRO of which 5 years are in clinical trials Direct experience of CTIS and IRAS CTA preparations and submissions is required Demonstrates ability to build and maintain relationships with other functions and clients, establishing collaborative partnerships and trust Detailed knowledge of ICH-GCP and national regulatory agency and ethics committee requirements and guidelines within EU/UK/EEA Stay informed about new guidelines and regulations Ability to anticipate problems relating to projects and to implement solutions. Excellent interpersonal skills Fluent knowledge of written and verbal English Highly organized and result oriented Ability to work independently as well as in a team environment Proficient knowledge of Microsoft Office packages including but not limited to Word, Power Point and Excel This job does not offer company sponsorship Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.