Bristol-Myers Squibb Company

CMC Senior Regulatory Associate

Hopewell, NJ, US
Oct 07, 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.

  • Represent regulatory CMC on matrix teams, with supervision, while providing guidance related to current regulatory requirements and expectations for marketing applications and clinical trial applications
  • Review and provide regulatory assessments on change controls, with supervision
  • Support the preparation of CMC policies and procedures
  • Support the preparation of CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness
  • Establish strong working relationships with diverse teams
  • Utilize electronic systems for dossier creation and tracking and change control assessment

Education, Experience, Skills:
  • Minimum of Bachelor's Degree, scientific discipline, with minimum of 2+ years of related experience
  • Knowledge of CMC regulatory requirements during development and post-approval is a plus
  • Knowledge of one or more areas of pharmaceutical development is desired, including drug substance and drug product and analytical methods.
  • Ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams and participate on multifunctional teams, with supervision
  • Ability to identify and communicate and resolve issues, with supervision.
  • Support the preparation of filings and ensure thoroughness, accuracy and timeliness
  • Ability to interpret global regulations and guidance, with supervision
  • Strong oral and written skills
  • Proficient with electronic systems