Associate Director, Regulatory Affairs CMC

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

The Associate Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.

The Associate Director, Regulatory Affairs CMC will be responsible for supporting the delivery of CMC regulatory strategy and submissions for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and the Senior Director, Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development, the Associate Director, Regulatory Affairs CMC will also serve as a subject matter expert (SME) 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 CMC strategy and submissions for assigned BicycleTx programs or projects, including CMC dossiers to support clinical trial applications;
Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions;
Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, authoring of responses to questions, audits and inspections;
Manage the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND, IMPD, amendments and annual reports) for assigned BicycleTx programs or projects;
Developing and maintaining internal cross-functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programs or projects;
May act as the Global/Regional CMC Regulatory Lead for assigned development programs;
May support preparations and attend regulatory authority meetings for assigned development programs;
Support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities;
Monitor the CMC regulatory landscape e.g., views of HAs, regulatory precedents, labeling differences and other CMC-specific issues, to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects;
Accountable for maintaining working knowledge of CMC 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 CMC Regulatory Affairs within the pharmaceutical or biotechnology industry; particularly relating to peptides, drug-conjugates and/or radiopharmaceuticals; any in-depth experience may be limited to one specific region (e.g. US or EU);
Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations;
Experience and knowledge in preparation of CMC sections 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;
Ability to communicate on topics of basic science is essential; an understanding of the drug product lifecycle from discovery to clinical trials to marketing 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;
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.