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 Description
The 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 formats
Plan, manage and track delivery of submission components. Coordinate submission publishing activities
Publish global regulatory submissions in eCTD and non eCTD formats
Support the implementation of BicycleTXs Document Management and Regulatory Information Management System
Develop and improve associated internal operational processes and procedures, such as SOPs, Work Instructions etc
Support the development and execution of training for all users of BicycleTx’s regulatory systems
Responsible for the maintenance of BicycleTx’s regulatory information within the RIM System
Collaborates 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 inspections
Collaborates 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 inspections
Maintains oversight of current and pending relevant regulatory submissions, providing associated metrics, insights and dashboards as needed
Maintenance of all of BicycleTx’s regulatory operations data and information, including regulatory requirements such as IDMP, SPOR etc
Monitors the regulatory operations landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects
Qualifications
Demonstratable experience in Regulatory Operations within the pharmaceutical or biotechnology industry
Working knowledge of FDA, EMA and ICH regulatory guidance and regulations, with in-depth knowledge of requirements for Regulatory Operations, including regulatory systems, publishing and data
Experience and involvement in the implementation of regulatory systems, processes and procedures; and in the development and delivery of associated training
Experience and knowledge in the preparation and publishing of regulatory submissions, such as INDs (in eCTD format), CTAs, or regional equivalents
An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required
Ability to communicate on topics of basic science is essential
Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions
Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity; experience with vendor management is desirable
Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects
Works effectively in a highly complex and fast-paced environment
Strong organizational and time management skills
Position may require domestic and international travel up to 10% of time
Additional Information
State-of-the-art campus environment with on campus restaurant and Montessori nursery
Flexible working environment
Competitive reward including annual company bonus
Employee recognition schemes
28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
Employer contribution to pension (employee does not have to contribute)
Life assurance cover 4x basic salary
Private Medical Insurance, including optical and dental cover.
Group income protection
Employee assistance program
Health Cash Plan
Access to company subsidized gym membership.
Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Cycle to work scheme
All 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.