Senior Manager, Regulatory Affairs CMC

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

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

The Senior Manager, Regulatory Affairs CMC will be responsible for supporting the development of CMC regulatory strategy and processes for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and the Director, Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development, the Senior Manager, 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, 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 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 CMC regulatory landscape, e.g., views of HAs, regulatory precedents, labeling differences and other CMC-specific issues and adapts to changes that may impact BicycleTx programs or projects

Qualifications

• Bachelor’s degree in a scientific field or post-graduate degree preferred
• Strong, demonstrable experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry is preferred; any in-depth experience may be limited to one specific region (e.g. US or EU); equivalent experience in CMC functional areas (such as Quality, Manufacturing, Pharmaceutical Development or Analytical), particularly relating to peptides, drug-conjugates and/or radiopharmaceuticals may be considered.
• Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations
• Experience and knowledge in preparation of CMC sections of INDs, CTAs, or regional equivalents is required
• Experience and knowledge in the supportive interactions with health authorities, including US FDA, is desirable
• 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; a working knowledge of global drug product development 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 envi