Senior Regulatory CMC Manager: Lead IND/MAA Submissions

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

Benefits offered by this job

Annual bonus (30% target)

Equity long-term incentive program

Retirement plan with company match

Health benefits

Job summary

Neurocrine Biosciences seeks a regulatory affairs leader to contribute to CMC strategy across development and commercial programs. You will drive IND/CTA activities, coordinate with FDA, and lead cross-functional teams to ensure timely submissions and regulatory success.

The role requires substantial CMC/regulatory expertise, strong project management, and the ability to influence stakeholders across global teams. Competitive salary and bonus structures are offered.

Qualifications

• Broad FDA regulatory knowledge, including current Good Manufacturing Practices.
• Experience creating and maintaining IND/CTA/MAA/NDA/BLA submissions.
• Ability to lead multiple teams and meet tight deadlines.
• Excellent communication, problem solving and analytical thinking.

Responsibilities

• Contribute to regulatory CMC strategy for assigned projects and IND/CTA preparation.
• Lead development of CMC regulatory plans for early approvals.
• Provide expertise on global CMC regulatory requirements to management and project teams.
• Advise product development teams on regulatory issues for submissions.
• Lead interactions with regulatory agencies during development and registration.
• Prepare regulatory submissions (IND/CTA/MAA/NDA/BLA) as needed.
• Create, review, and edit regulatory reports and submissions.
• Engage with stakeholders to shape science-based regulatory decisions.
• Serve as CMC liaison with partner companies and contract manufacturers.

Skills

Regulatory affairs

CMC knowledge

FDA interactions

Project leadership

Regulatory strategy

Education

BS/BA Life/Health Sciences

Master's degree in Life/Health Sciences

PhD

Tools

eCTD submission software

Electronic document management systems

Job description

Neurocrine Biosciences seeks a regulatory affairs leader to contribute to CMC strategy across development and commercial programs. You will drive IND/CTA activities, coordinate with FDA, and lead cross-functional teams to ensure timely submissions and regulatory success.

The role requires substantial CMC/regulatory expertise, strong project management, and the ability to influence stakeholders across global teams. Competitive salary and bonus structures are offered.