Associate Director, Global Regulatory CMC Strategy

Bristol Myers Squibb; Alabama; On-site; USD 164,000 - 199,000; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Paid Time Off

Job summary

Bristol Myers Squibb is seeking an experienced GRS-CMC Associate Director to lead content development, compilation, maintenance and review of the Quality Module for regulatory submissions across global markets. You will interface with Global Regulatory Sciences and GPS/CTDO teams, assessing Manufacturing Change Controls for global impact and guiding technical teams on global change management.

You will provide strategic CMC regulatory expertise for development project teams, coordinate with

Qualifications

• Minimum BA/BS Degree.
• 8+ years Pharmaceutical industry experience – prefer knowledge of small molecules, biology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy.
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable.
• Expertise in the biological, cell therapy and/or small molecule modalities, drug development process and analytical methods.

Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for small molecules, biologics, combination and device, cell therapy products development and/or commercial products.
• Independently provide strategic guidance/input related to current regulatory requirements and expectation for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
• Independently manage and prioritize multiple complex projects.
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness.

Skills

Cross-functional collaboration

Project management

Regulatory strategy

Communication

Strategic thinking

Education

BA/BS Degree

Tools

Electronic systems

Job description

Bristol Myers Squibb is seeking an experienced GRS-CMC Associate Director to lead content development, compilation, maintenance and review of the Quality Module for regulatory submissions across global markets. You will interface with Global Regulatory Sciences and GPS/CTDO teams, assessing Manufacturing Change Controls for global impact and guiding technical teams on global change management.

You will provide strategic CMC regulatory expertise for development project teams, coordinate with