CMC Regulatory Manager/Group Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Responsibilities:


Represent regulatory CMCon matrix teams while providing strategic guidance related to current regulatory requirements and expectations for marketing applicationsand/or clinical trial applications for small molecule projects
Review and provide regulatory assessments on change controls (commercial and/or development products)
Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
Manage collaborative relationships with diverse teams
Utilize electronic systems for dossier creation and tracking regulatory information


Education, Experience, Skills:


Minimum of Bachelor's Degree, scientific discipline, with minimum of 4-6 years of related experience
CMC regulatory experience, including post-approval experience desired
Knowledge of CMC regulatory requirements during development and post-approval
Knowledge of pharmaceutical development, including drug substance and drug product and analytical methods.
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
Occasional Travel Required


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.

Company: Bristol-Myers Squibb

Req Number: R1522067_EN

Updated: 2020-03-01 00:00:00.000 UTC

Location: New Brunswick,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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