Job Description

The Manager of Regulatory Affairs will be responsible for the development, execution and tracking of regulatory submissions for assigned BicycleTx programs or projects.

The Manager Regulatory Affairs may also be responsible for supporting the development of regulatory strategy and processes for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and senior members of the Regulatory Affairs team. As an integral member of the team that will be tasked with product development, the Manager Regulatory Affairs may also serve as a subject matter expert for assigned activities, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.

• Responsible for the development and execution of global regulatory submissions for assigned BicycleTx programs or projects, including clinical trial applications
• Responsible for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file
• Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions, responses to questions, audits and inspections
• May be responsible for the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned BicycleTx programs or projects, which may include selected key strategic submissions such as pediatric or orphan drug etc
• Developing and maintaining internal cross-functional relationships to support the development and execution of regulatory submissions for assigned BicycleTx programs or projects
• Supports the Global/Regional Regulatory Lead for assigned development programs
• May serve as primary contact with Health Authorities (HA) and/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
• Partners with Regulatory Affairs and cross-functional colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic-specific issues and adapts to changes that may impact BicycleTx programs or projects
• Responsible for maintaining oversight of current and pending relevant regulatory approvals in therapeutic areas relevant to the assigned BicycleTx programs or projects
• Accountable for maintaining working knowledge of laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge

Qualifications

• Bachelor’s degree in a scientific field or post-graduate degree preferred
• Demonstrable experience in Regulatory Affairs within the pharmaceutical or biotechnology industry; any in-depth experience may be limited to one specific region (e.g. US or EU)
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
• Experience and knowledge in preparation of INDs, CTAs, or regional equivalents is desirable
• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required
• Experience and knowledge of some key regulatory pathways for product development, for example pediatrics, orphan drugs, is desirable
• Therapeutic experience in oncology is desirable
• Ability to communicate on topics of basic science is essential; a working knowledge of global drug development including preclinical & clinical is required
• Ability to proactively identify risks and develop risk mitigation strategies
• Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
• Collaborative, and able to build cross-functional relationships internally and externally
• 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 limited domestic and international travel

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

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.