Senior Manager, Regulatory Affairs CMC

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company focused on developing a new class of medicines using bicyclic peptides, leveraging Nobel Prize-winning science.

Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops, which stabilize their structural geometry for high affinity and selectivity in target binding. The company is evaluating several candidates, including zelenectide pevedotin, BT5528, and BT7480, in clinical trials. Bicycle is headquartered in Cambridge, UK, with key functions and leadership located in Cambridge, MA.

This is a full-time hybrid role for a Senior Manager, Regulatory Affairs CMC at Bicycle Therapeutics. The position is primarily based in Cambridge, MA, with some work-from-home flexibility. The Senior Manager will be responsible for managing regulatory compliance, developing regulatory strategies, preparing and submitting regulatory documents, and ensuring quality systems are in place for product development. Daily tasks include collaborating with cross-functional teams, providing regulatory guidance, and maintaining updated knowledge of regulatory requirements and submissions.

• Strong understanding of Regulatory Compliance and Regulatory Requirements
• Experience in Regulatory Affairs and preparing Regulatory Submissions
• Knowledge of Quality Systems relevant to the biopharmaceutical industry
• Excellent written and verbal communication skills
• Ability to work effectively in a hybrid environment
• Bachelor's degree in Life Sciences, Regulatory Affairs, or related field; advanced degree preferred
• Experience in oncology and peptide-based therapeutics is a plus

Bicycle Therapeutics is an equal opportunities employer and welcomes applications from all qualified candidates.