Director of Regulatory Affairs

A clinical-stage oncology biotech is seeking a Director of Regulatory Affairs to lead global regulatory strategy across its pipeline.This is a hands-on leadership role within a lean, high-growth environment, offering direct interaction with executive leadership and the opportunity to shape regulatory direction across multiple programs.Key Responsibilities:Lead global regulatory strategy for oncology assets (early–mid stage, with progression toward registrational development)Assist in authoring and oversee INDs, IND amendments, and briefing documents (including support for future NDA/BLA submissions)Liaison with the FDA, leading key interactions Provide regulatory guidance on clinical development, including study design, endpoints, and overall strategyPartner cross-functionally with Clinical, CMC, and other teams to ensure aligned regulatory executionEstablish and refine regulatory processes and infrastructure appropriate for a scaling biotechMentor junior team members and contribute to the growth of the RA functionRequirements:10–15+ years of Regulatory Affairs experience within biotech/pharma, with a strong focus in oncology or rare diseaseProven experience leading IND submissions and managing FDA interactions independentlyExposure to NDA/BLA submissions strongly preferredDeep understanding of US regulatory frameworks; global experience (EMA/ICH) a plusExperience working in small to mid-sized biotech environmentsAbility to operate both strategically and hands-on in a fast-paced settingStrong communication and cross-functional leadership skillsPreferred Qualifications:Advanced degree (PhD, PharmD, or MSc) in a life sciences disciplinePrior experience supporting or leading registrational strategy for oncology productsExperience with accelerated/expedited approval pathways in the USBackground in both solid tumours and haematologic malignanciesPrevious involvement in advisory committee preparations or regulatory inspectionsExperience building or scaling a Regulatory Affairs function in an emerging biotech