Associate Director, Regulatory Affairs

Job Description CK Group are working with a very wellbacked biotechnology company, with a strong pipeline who arelooking for an Associate Director, Regulatory Affairs, for asix-month contract. The role will be in support of their expandingOncology portfolio, extensive Oncology experience is an absolutemust, radiopharmaceuticals experience would be highly advantageous.Ideally the role will be hybrid, with three days a week in theCambridge office, though a fully remote role could be consideredfor an ideal candidate. RESPONSIBILITIES: As Associate Director,Regulatory Affairs you will be responsible for oversight of theoperational execution of Regulatory submissions for their assignedprograms or projects, working closely with cross-functionalcolleagues. Key duties will include: - Responsibility for thedevelopment and execution of regulatory strategy for assignedprograms or projects, including development and maintenance of theRegulatory Plan. - Oversight of the preparation and execution ofglobal regulatory submissions for assigned programs or projects, incollaboration with the Regulatory Lead. - Responsibility for themaintenance of regulatory files and tracking databases, includingrelevant parts of the trial master file. - Manage the preparation,drafting, review, risk analysis and mitigation planning ofsubmissions for assigned programs or projects, which may includesome strategic submissions such as INDs, CTAs, NDAs, MAAs,pediatric plans, orphan drug designations and/or expedited programsubmissions, etc. - Monitoring the regulatory landscape toanticipate and adapt to changes that may impact assigned programsor projects. - Development and maintenance of internalcross-functional relationships to support the development andexecution of regulatory strategy assigned programs or projects.QUALIFICATIONS: As Associate Director, Regulatory Affairs you willrequire: - Bachelor’s degree in a scientific field or post-graduatedegree preferred. - Extensive industry-based experience inRegulatory Affairs in support of Oncology products, ideally with aradiopharmaceuticals background also. - Working knowledge of FDA,EMA and ICH regulatory guidance and regulations. - Experience andknowledge in preparation of INDs, CTAs, NDAs, MAAs or regionalequivalents is required. - An understanding of the drug productlifecycle from discovery to clinical trials to marketing isrequired. - Ability to proactively identify risks and develop riskmitigation strategies. BENEFITS: Excellent day rate. APPLY: It isessential that applicants hold entitlement to work in the UK.Please quote job reference 127 267 in all correspondence. If thisposition isn't suitable but you are looking for a new role, or ifyou are interested in seeing what opportunities are out there, headover to our LinkedIn page (cka-group) and follow us to see ourlatest jobs and company news.