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Senior Reporting Manager
4 months ago
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.
This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development.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, MA.
The Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects.
The Associate Director Regulatory Affairs will be responsible for oversight of the operational execution of Regulatory submissions for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues.
As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
Responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects, including development and maintenance of the Regulatory Plan, working with the Director of Regulatory Affairs and other colleagues as appropriate
Oversee the preparation and execution of global regulatory submissions for assigned BicycleTx programs or projects, in collaboration with the Regulatory Lead.
Collaborate with internal colleagues, external regulatory and quality consultants, and external organizations, to support the timely execution of regulatory submissions, authoring of responses to questions, audits and inspections
Manage the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned BicycleTx programs or projects, which may include some strategic submissions such as INDs, CTAs, NDAs, MAAs, pediatric plans, orphan drug designations and/or expedited program submissions, etc.
Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy assigned BicycleTx programs or projects
May act in collaboration with the as Global/Regional Regulatory Lead for assigned development programs
May serve as primary contact with Health Authorities (HA) &/or external collaborators globally for assigned BicycleTx programs or projects.
May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
May support preparations and attend regulatory authority meetings for assigned development programs
Partner with the Director Regulatory Affairs to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic-specific issues
Maintain oversight of current and pending relevant regulatory approvals
Maintain working knowledge of laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge
Bachelor's degree in a scientific field or post-graduate degree preferred
Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
Experience and knowledge of some of the key regulatory pathways for product development, for example pediatrics plans, orphan drugs, Regulatory Agency advice, expedited development (e.g. Ability to proactively identify risks and develop risk mitigation strategies
Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions, and adapt to changing priorities and deadlines
Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity
Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects
Strong organizational and time management skills
Position may require some domestic and international travel
State-of-the-art campus environmentwith 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.
~ 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
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve.
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.
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