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Regulatory Strategy Manager at Neurocrine Biosciences - ApplyBlast

Regulatory Strategy Manager

Neurocrine Biosciences

4 months ago

3.7 on Glassdoor

San Diego, CA

Onsite

Full Time

Senior

0 applicants

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About this role

This Senior Regulatory Affairs role supports the execution of regulatory strategies for drug development programs at a biopharmaceutical company. Key duties include preparing regulatory submissions, managing document packages, providing cross-functional expertise, and ensuring compliance with FDA and ICH guidelines. The position involves analyzing global regulations and developing strategies to support clinical and nonclinical activities.

Responsibilities

Develop and file INDs, CTAs, and briefing documents
Coordinate and author regulatory submission packages
Provide regulatory expertise on cross-functional teams
Maintain awareness of global regulatory strategies
Review clinical study documentation including protocols and consents

Skills

Qualifications

BS/BA in Life/Health SciencesPharmD or PhD6+ Years Industry Experience3 Years Regulatory Affairs ExperienceExperience with FDA Regulations

About Neurocrine Biosciences

neurocrine.com

Headquarters

San Diego, California, United States

Company Size

1001-5000 employees

Founded

1992

View Profile

Neurocrine Biosciences is a biopharmaceutical company focused on discovering and developing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. With over 30 years of research, the company works to bring hope to people living with rare diseases and conditions that lack viable treatment options. Neurocrine develops and markets approved medicines while maintaining an active clinical pipeline across multiple therapeutic areas.