Director, Regulatory Affairs

About Us

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD‑1 x VEGF bispecific antibody, as well as novel antibody‑drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors.

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Our Director, Regulatory Affairs, will support the development and implementation of global regulatory activities for investigational products within the company’s pipeline. The successful candidate will have hands‑on expertise in developing robust regulatory strategies for novel oncology compounds. Knowledge of global regulations is necessary to provide regulatory support to ongoing global clinical trials and to review global submissions to these trials. This individual will operate in a high visibility role actively contributing to the development and implementation of regulatory strategy including identifying and assessing regulatory risks and interfacing with the authorities.

They will collaborate with‑functional teams to provide regulatory guidance, drive health authority interactions, and manage regulatory submissions. As a key liaison between internal teams and external partners, you will help communicate regulatory plans and updates, ensuring alignment with company goals. This individual must be comfortable in a small company environment and bring hands‑on experience.

• Develop and implement innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, Asia, EU, Australia).
• Represent Regulatory on Program Teams to lead global regulatory strategy for assigned programs across development stages.
• Provide strategic, operational and tactical regulatory insight on one or more complex global programs in clinical development with a focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients.
• Serve as the global regulatory lead (GRL) on cross‑functional teams for assigned programs, providing strategic input and regulatory expertise.
• Author regulatory documents (e.g., INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/MAA, submissions as needed.
• Develop/author and execute global regulatory for complex strategies.
• Lead regulatory interactions with Health Authorities, external partners, and vendors for assigned products/projects.
• Work closely and collaboratively with other functions in the preparation of high‑quality, timely submissions to Regulatory Agencies.

• Review and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness.
• Authoring Health Authority responses alongside subject matter experts.
• Management of submission activities for initial INDs, BLAs, amendments, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests, orphan drug designation requests, and Pediatric Study Plans.
• Reviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness.
• Preparing, reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors/consultants.

• Bachelor’s degree in a scientific discipline required;
  Advanced scientific degree (Pharm
  
  D or PhD) preferred.
• 8–10 years of relevant pharmaceutical/biotechnology…