Director or Senior Director, Regulatory CMC

SciPro is partnered with an exciting mid stage oncology biotech that is seeking a Director or Senior Director, Regulatory CMC to join their team full-time. This role will lead the development and execution of global regulatory strategies and play a key role in guiding regulatory submissions, ensuring compliance throughout the product lifecycle, from development to commercialization.We’re looking for a hands on Regulatory CMC expert and strategic leader who thrives on solving complex challenges and navigating ambiguity. The ideal candidate will have a small molecules background, experience leading HA interactions, writing module 3 components, and global submission experience.This is a hybrid position with 2-3 days onsite in San Francisco or San Diego. The team is open to candidates without an oncology background.ResponsibilitiesLead and implement CMC regulatory strategies across their late stage pipeline, including registration and lifecycle management.Prepare, review, and submit high-quality regulatory documentation (e.g., INDs, NDAs, amendments, supplements) aligned with global health authority requirements.Serve as the primary POC for CMC-focused Health Authority interactionsServe as a primary POC for CMC-related regulatory interactions with agencies such as FDA, EMA, PMDA, etc.Oversee submission readiness and post-submission activitiesProvide strategic input to cross-functional teams to ensure development plans align with regulatory expectations.QualificationsAdvanced degree (PhD, PharmD, MS) with 10+ years, or Bachelor's degree with 10+ years, of relevant experience in Regulatory Affairs, with a strong focus on CMC.Proven experience with Phase 3 global programsRecent small molecules experienceDemonstrated success in authoring and compiling regulatory dossiers for global filings.Veeva Vault experience