Senior Counsel, Drug Development & Regulatory Affairs

Bristol Myers Squibb; Princeton (NJ); On-site; USD 253,748 - 299,460; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Annual discretionary bonus

Job summary

Bristol Myers Squibb in Lawrenceville, NJ, is seeking a Counsel, Drug Development to join our global team. You will support design and execution of clinical trials and regulatory submissions, review documents for health authorities, and collaborate with cross‑functional partners to manage risk and drive compliant drug development.

The role requires a J.D. or foreign equivalent with licensing and several years in pharmaceutical regulatory law, with experience drafting and negotiating clinical

Qualifications

• J.D., LL.M., or foreign equivalent degree plus five years of related legal experience.
• Active license to practice law in at least one jurisdiction.
• Five years of experience in pharma regulatory law, global clinical trials, drug development, and health authority submissions.
• Three years in pharma/biotech/medical device and drafting, reviewing, and negotiating clinical trial contracts.

Responsibilities

• Support Drug Development team with the design and execution of clinical trials and health authority submissions.
• Review documents submitted to health authorities (FDA, EMA, TGA, etc.).
• Collaborate with teams to identify, prioritize, escalate, and resolve drug development issues.
• Provide proactive legal/regulatory advice on trial design and data generation.
• Act as legal point of contact for the Asia Pacific region.
• Assist regional market lawyers on drug development issues.
• Provide comprehensive legal advice on sponsorship and clinical trial contracting.
• Up to 10% telecommuting.

Skills

Legal expertise

Regulatory affairs

Clinical trial understanding

Contract negotiation

Education

J.D./LL.M. or foreign equivalent

Job description

Bristol Myers Squibb in Lawrenceville, NJ, is seeking a Counsel, Drug Development to join our global team. You will support design and execution of clinical trials and regulatory submissions, review documents for health authorities, and collaborate with cross‑functional partners to manage risk and drive compliant drug development.

The role requires a J.D. or foreign equivalent with licensing and several years in pharmaceutical regulatory law, with experience drafting and negotiating clinical