Global CMC Regulatory Director

Bristol Myers Squibb; Brisbane; On-site; AUD 180,000 - 280,000; Full time

Benefits offered by this job

Wellbeing support

Retirement plan

Insurance offerings

Job summary

Bristol Myers Squibb is seeking a senior Regulatory CMC leader for our Brisbane, Australia location. You will develop strategic regulatory direction and oversee CMC submissions, ensuring high-quality, timely deliverables.

You will lead cross-functional teams, mentor staff, and drive adherence to global guidelines, while staying ahead of regulatory paradigm shifts and representing GRS-CMC in key meetings.

Qualifications

• Minimum BA/BS Degree.
• 10+ years pharmaceutical or related experience, including 8+ years regulatory CMC.
• Multidisciplinary experience preferred.

Responsibilities

• Develop and communicate strategic direction based on global regulatory guidelines and experience.
• Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness.
• Review submissions from CMC Leads for clarity of both strategic and technical content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Manage and actively support growth and development of direct reports.
• Actively participates in leadership or department meetings.
• Anticipate and communicate possible regulatory paradigm shifts.
• Participate in product fact finding meetings and/or R&D forums representing GRS-CMC.
• Support the preparation of CMC policies and procedures.
• Ensure Regulatory Compliance: monitor and verify timely data entry into the Regulatory Information Management system.

Skills

CMC knowledge

Regulatory strategy

Leadership

Cross-functional teamwork

Regulatory compliance

Communication skills

Travel readiness

Education

BA/BS Degree

Tools

Regulatory information management system

Electronic dossier systems

Job description

Bristol Myers Squibb is seeking a senior Regulatory CMC leader for our Brisbane, Australia location. You will develop strategic regulatory direction and oversee CMC submissions, ensuring high-quality, timely deliverables.

You will lead cross-functional teams, mentor staff, and drive adherence to global guidelines, while staying ahead of regulatory paradigm shifts and representing GRS-CMC in key meetings.