Bristol-Myers Squibb Company

Regulatory CMC Manager/Group Manager

Hopewell, NJ, US
May 12, 2018
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Regulatory CMC Manager/Group Manager
  • Represent regulatory CMC on and/or lead cross-functional matrix teams
  • Provide strategic guidance related to current regulatory requirements and expectations for marketing applications and clinical trial applications for small molecule projects.
  • Review and provide regulatory assessments on post-approval change controls
  • Prepare and manage CMC submissions for all global markets, while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
  • Manage relationships with diverse teams
  • Utilize electronic systems for dossier creation and tracking

Education, Experience, Skills:
  • Minimum of Bachelor's Degree in scientific discipline, with minimum of 4-6 years of pharmaceutical industry experience
  • Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods.
  • Knowledge of CMC regulatory requirements related to drug development and post-approval
  • Post-approval regulatory experience advantageous
  • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
  • Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness
  • Ability to interpret global regulations and guidance
  • Strong oral and written skills
  • Proficient with electronic systems