Associate Director, Regulatory Documentation & Content Strategy

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 171,000 - 207,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

401(k) & financial protection

Paid Time Off

Job summary

Bristol Myers Squibb is seeking a highly experienced regulatory documentation professional to coordinate and author pivotal regulatory submissions. You will integrate scientific, medical, and regulatory input from development teams across assets and geographies to produce compliant, high-quality documentation.

The role requires strong communication, project leadership, and deep knowledge of global regulatory requirements, with a focus on speed and consistency of submissions.

Qualifications

• PharmD/PhD/MD in a relevant discipline or Master's/Bachelor's with ~10 years in pharma regulatory docs.
• Expert writing and management of clinical/regulatory documents (e.g., CTD, briefing docs).
• Ability to analyze complex data and ensure global regulatory compliance.

Responsibilities

• Author complex regulatory documents for submissions.
• Coordinate timelines with document subteams and plan content.
• Lead or co-lead teams to define content and organization for CTD summaries.

Skills

Regulatory writing

Document coordination

Cross-functional collaboration

Attention to detail

Global regulatory knowledge

Education

PharmD/PhD/MD or equivalent

Master's/Bachelor's with 10 years' experience

Tools

Document management systems

CTD/Regulatory submissions

Job description

Bristol Myers Squibb is seeking a highly experienced regulatory documentation professional to coordinate and author pivotal regulatory submissions. You will integrate scientific, medical, and regulatory input from development teams across assets and geographies to produce compliant, high-quality documentation.

The role requires strong communication, project leadership, and deep knowledge of global regulatory requirements, with a focus on speed and consistency of submissions.