Senior Regulatory Strategy Leader - Global Submissions

Neurocrine Biosciences; San Diego (CA); On-site; USD 158,000 - 216,000; Full time

Benefits offered by this job

Retirement plan (company match)

Paid vacation, holidays and personal (

Job summary

Neurocrine Biosciences seeks an experienced Regulatory Affairs leader to provide project leadership for regulatory submissions and process development. You will work with US and international authorities, cross-functional teams, and CROs to optimize submissions and ensure regulatory compliance across product programs.

Responsibilities include coordinating IND/CTA activities, shaping global strategies, and mentoring less experienced colleagues.

Qualifications

• BS/BA in Life/Health Sciences and 8+ years regulatory affairs experience.
• Master’s degree preferred and 6+ years related experience.
• Experience with FDA regulations and ICH guidelines for submissions.
• Ability to lead multiple teams and meet deadlines.
• Excellent communication and analytical thinking abilities.

Responsibilities

• Provide project leadership to develop, review and/or file regulatory submissions.
• Provide regulatory representation and expertise on cross-functional teams.
• Develop global regulatory strategies for CMC, nonclinical and clinical activities.
• Maintain regulatory awareness of global strategies for similar products.
• Develop and manage timelines for regulatory submissions.
• Lead, coordinate, author, and review regulatory filing documents.
• Lead regulatory review of clinical study documentation and recruitment materials.
• Mentor or train colleagues and contribute to strategic regulatory plans.

Skills

Regulatory leadership

FDA regulations

ICH guidelines

Regulatory submissions

Project management

Cross-functional collaboration

Communication skills

Education

BS/BA Life/Health Sciences

Master’s degree Life/Health Sciences

Job description

Neurocrine Biosciences seeks an experienced Regulatory Affairs leader to provide project leadership for regulatory submissions and process development. You will work with US and international authorities, cross-functional teams, and CROs to optimize submissions and ensure regulatory compliance across product programs.

Responsibilities include coordinating IND/CTA activities, shaping global strategies, and mentoring less experienced colleagues.