Regulatory Strategy Lead — Submissions & Compliance

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 180,000 - 210,000; Full time

Job summary

Neurocrine Biosciences, Inc. is seeking an experienced Regulatory Affairs professional to provide project leadership for regulatory submissions and process improvements.

You will work with regulatory leadership to prepare submissions, maintain processes, and ensure compliance with global requirements. The role involves coordinating with internal departments and external partners to drive early approvals of clinical trial applications and labeling decisions while staying aligned with company

Qualifications

• BS/BA in Life/Health Sciences with 8+ years in regulatory affairs in drug development.
• Experience with FDA regulations and ICH guidelines for regulatory submissions.
• Leadership experience: minimum 2 years in a lead capacity.

Responsibilities

• Provide project leadership to develop, review and file INDs, CTAs and regulatory documents such as DSURs.
• Collaborate on global regulatory strategies with cross-functional teams (CMC, nonclinical, clinical).
• Develop and manage regulatory submission timelines and documents.
• Mentor or train less experienced colleagues to share best practices.
• Interface with US and international regulatory authorities as required.
• Lead or contribute to regulatory filing document reviews and strategy.

Skills

Regulatory affairs

FDA regulations

ICH guidelines

Education

BS/BA in Life/Health Sciences

Master's in Life/Health Sciences preferred

Job description

Neurocrine Biosciences, Inc. is seeking an experienced Regulatory Affairs professional to provide project leadership for regulatory submissions and process improvements.

You will work with regulatory leadership to prepare submissions, maintain processes, and ensure compliance with global requirements. The role involves coordinating with internal departments and external partners to drive early approvals of clinical trial applications and labeling decisions while staying aligned with company