Associate Director, Regulatory Affairs

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

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;
Responsible for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file;
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.;
Monitor the regulatory landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects;
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.

Qualifications

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 in preparation of INDs, CTAs, NDAs, MAAs or regional equivalents is required;
Experience and knowledge in the supportive interactions with health authorities, including US FDA, EMA and/or EU Member States, is desirable;
An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required;
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. Fast Track, Breakthrough Designation, PRIME) 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 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;
Works effectively in a highly complex and fast-paced environment;
Strong organizational and time management skills;
Position may require some domestic and international travel.