Job Title

CK Group are working with a very well backed biotechnology company with a strong pipeline who are looking for an Associate Director, Regulatory Affairs for a six-month contract. The role will be in support of their expanding Oncology portfolio, extensive Oncology experience is an absolute must, radiopharmaceuticals experience would be highly advantageous. Ideally the role will be hybrid, with three days a week in the Cambridge office, though a fully remote role could be considered for an ideal candidate.RESPONSIBILITIES:As Associate Director, Regulatory Affairs you will be responsible for oversight of the operational execution of Regulatory submissions for their assigned programs or projects, working closely with cross-functional colleagues.Key duties will include:Responsibility for the development and execution of regulatory strategy for assigned programs or projects, including development and maintenance of the Regulatory PlanOversight of the preparation and execution of global regulatory submissions for assigned programs or projects, in collaboration with the Regulatory LeadResponsibility for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master fileManage the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned programs or projects, which may include some strategic submissions such as INDs, CTAs, NDAs, MAAs, paediatric plans, orphan drug designations and/or expedited program submissions, etcMonitoring the regulatory landscape to anticipate and adapt to changes that may impact assigned programs or projectsDevelopment and maintenance of internal cross-functional relationships to support the development and execution of regulatory strategy assigned programs or projectsQUALIFICATIONS:As Associate Director, Regulatory Affairs you will require:Bachelors degree in a scientific field or post-graduate degree preferredExtensive industry-based experience in Regulatory Affairs in support of Oncology products, ideally with a radiopharmaceuticals background alsoWorking knowledge of FDA, EMA and ICH regulatory guidance and regulationsExperience and knowledge in preparation of INDs, CTAs, NDAs, MAAs or regional equivalents is requiredAn understanding of the drug product lifecycle from discovery to clinical trials to marketing is requiredAbility to proactively identify risks and develop risk mitigation strategiesBENEFITS:Excellent day rateAPPLY:It is essential that applicants hold entitlement to work in the UK. Please quote job reference 127267 in all correspondence.