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Regulatory Strategy Manager at Neurocrine Biosciences - ApplyBlast

Regulatory Strategy Manager

Neurocrine Biosciences

3 months ago

3.7 on Glassdoor

San Diego, CA

Onsite

Full Time

Senior

0 applicants

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About this role

This role supports the strategic execution of regulatory programs for drug development, coordinating the preparation of submission packages such as INDs, CTAs, and NDAs. The incumbent collaborates with senior leadership to ensure compliance with FDA and ICH guidelines while managing timelines for global regulatory strategies across CMC and clinical activities.

Responsibilities

Develop and file INDs, CTAs, and briefing documents for regulatory submissions
Coordinate document packages for NDA/BLA approvals and annual reports
Collaboratively develop global regulatory strategies for CMC and clinical activities
Review clinical protocols and informed consent documents for compliance
Conduct regulatory research and communicate emerging regulations to management

Skills

Qualifications

BS/BA in Life/Health SciencesPharmDPhDMaster’s in Life/Health SciencesRegulatory Affairs Certification (optional)

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.