Senior Regulatory Strategy Manager

Role: Senior Regulatory Affairs leader supporting neuropharmaceutical development at Neurocrine Biosciences, focusing on regulatory strategy, submission readiness, and process improvement. Responsibilities: develop and review INDs, CTAs, briefing documents, and maintain regulatory applications; lead global regulatory strategies aligning with CMC, clinical, and nonclinical activities; manage submission timelines and author critical documents such as DSURs and annual reports; interface with US and international agencies; develop SOPs and ensure compliance with regulations; mentor team members and contribute to strategic planning. Requirements: BS/BA in Life/Health Sciences with 8+ years in industry regulatory roles, including 6+ years in drug development at research-based pharma, with at least 2 years in a leadership capacity; strong expertise in FDA regulations, ICH guidelines, and global regulatory frameworks; excellent project management, communication, and leadership skills. Preferred: Master’s degree; experience with US and ex-US regulations. High-Value: support for neurological, psychiatric, endocrine, and immunological therapeutics; involvement in IND/CTA filings, clinical trial documentation review, and regulatory strategy development; experience with cross-functional teams and external agencies. WorkSetup: not specified; requires independent work and leadership in regulatory processes.