Regulatory Strategy Manager

$132.7k - $182k

Neurocrine Biosciences

San Diego, CA

Responsibilities

Develop, review, and file regulatory submissions including INDs, CTAs, DSURs, and annual reports
Collaborate on global regulatory strategies supporting CMC, nonclinical, and clinical development programs
Conduct regulatory intelligence research on competitive products and communicate emerging regulations to stakeholders
Review clinical study documentation including protocols, informed consent forms, and recruitment materials
Lead and coordinate preparation of regulatory filing documents with cross-functional project teams

Requirements

Bachelor's degree in life or health sciences plus 6+ years industry experience with minimum 3 years in regulatory affairs at research-based pharmaceutical company
Master's degree in life or health sciences with 4+ years related experience, or PharmD/PhD with 2+ years experience
Two years leading regulatory affairs in drug development
Knowledge of FDA regulations and ICH guidelines for regulatory submissions
Strong project management, verbal and written communication skills
Ability to work independently and lead cross-functional teams with minimal direction
Proficiency with computer systems and excellent analytical thinking abilities

Compensation: $132,700-$182,000 base salary

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Vacancy posted 6 days ago

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