Senior Manager Regulatory Affairs CMC

Company Description

Bicycle Therapeuticsis a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle®molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle®Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; 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®Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle®technology to develop therapies for diseases beyond oncology.

Bicycle Therapeuticsis headquartered inCambridge, UK, with many key functions and members of its leadership team located inCambridge, Mass. For more information, visit bicycletherapeutics.com.

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.

You 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.

Key Responsibilities

• Responsible for the development and execution of regulatory strategy and submissions for assigned BicycleTx programs or projects, with a focus on regulatory CMC, including 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
• Accountable for maintaining working knowledge of CMC laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge

This is a hybrid working arrangement, with a minimum of 1-2 days onsite from our Cambridge, UK office.

We are also open to those that can commit to a minimum of 0.8FTE (4 day week).

We are only considering candidates who have a mix of CMC and Clinical Regulatory Affairs experience.

Qualifications

Key Skills and Competencies

• 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; particularly relating to peptides and drug‑conjugates; any in‑depth experience may be limited to one specific region (e.g. US or EU).
• General clinical regulatory experience supporting global clinical trial applications (not limited to CMC) is essential.
• 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
• 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 environment
• Strong organisational and time management skills
• Position may require some domestic and international travel

Additional Information

• State‑of‑the‑art campus environment
• Competitive reward including annual company bonus
• 28 days annual leave in addition to bank holidays
• Employer contribution to pension (employee does not have to contribute)
• Life assurance cover 4x basic salary
• Private Medical Insurance, including optical and dental cover
• Health Cash Plan
• 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. 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.