Manager, Regulatory Operations

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. Culture is key and all Bicycle employees actively embrace and role model our company values: We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients. We are Dedicated to our Mission. You can’t change the world if you don’t have determination.We are One Team. We only succeed when we work together. Job DescriptionThe Manager Regulatory Operations will support activities for the development, implementation and management of BicycleTx regulatory systems and operational processes, reporting to the Associate Director of Regulatory Operations. You will work closely with the Associate Director Regulatory Operations and support the implementation of BicycleTx’s planned Document Management, Regulatory Information and Regulatory Publishing systems and associated operational processes (SOPs, etc.). Following implementation, you will be responsible for maintaining these systems, and for the planning and execution of all Regulatory publishing activity for BicycleTx’s programs. You will also serve as a subject matter expert (SME) for Regulatory Operations, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements. Lead and manage planning, compilation and publishing of global regulatory submissions in eCTD and non eCTD formatsPlan, manage and track delivery of submission components. Coordinate submission publishing activitiesPublish global regulatory submissions in eCTD and non eCTD formatsSupport the implementation of BicycleTXs Document Management and Regulatory Information Management SystemDevelop and improve associated internal operational processes and procedures, such as SOPs, Work Instructions etcSupport the development and execution of training for all users of BicycleTx’s regulatory systemsResponsible for the maintenance of BicycleTx’s regulatory information within the RIM SystemCollaborates with internal and external regulatory affairs and cross-functional colleagues, to ensure the execution of regulatory submissions, including, but not limited to, initial submissions, responses to questions, audits and inspectionsCollaborates with internal and external regulatory affairs and cross-functional colleagues, to ensure robust management and tracking of regulatory information to support key compliance activities including, but not limited to, change management, audits and inspectionsMaintains oversight of current and pending relevant regulatory submissions, providing associated metrics, insights and dashboards as neededMaintenance of all of BicycleTx’s regulatory operations data and information, including regulatory requirements such as IDMP, SPOR etcMonitors the regulatory operations landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects QualificationsDemonstratable experience in Regulatory Operations within the pharmaceutical or biotechnology industryWorking knowledge of FDA, EMA and ICH regulatory guidance and regulations, with in-depth knowledge of requirements for Regulatory Operations, including regulatory systems, publishing and dataExperience and involvement in the implementation of regulatory systems, processes and procedures; and in the development and delivery of associated trainingExperience and knowledge in the preparation and publishing of regulatory submissions, such as INDs (in eCTD format), CTAs, or regional equivalentsAn understanding of the drug product lifecycle from discovery to clinical trials to marketing is requiredAbility to communicate on topics of basic science is essentialAdaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutionsHighly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity; experience with vendor management is desirableWorks proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projectsWorks effectively in a highly complex and fast-paced environmentStrong organizational and time management skillsPosition may require domestic and international travel up to 10% of time Additional InformationState-of-the-art campus environment with on campus restaurant and Montessori nurseryFlexible working environmentCompetitive reward including annual company bonusEmployee recognition schemes28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annuallyEmployer contribution to pension (employee does not have to contribute)Life assurance cover 4x basic salaryPrivate Medical Insurance, including optical and dental cover.Group income protectionEmployee assistance programHealth Cash PlanAccess to company subsidized gym membership.Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.Cycle to work schemeAll your information will be kept confidential according to EEO guidelines.Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.