Regulatory CMC Associate Director

Summary

The position will support development of CMC strategy for post approval changes for small molecules as well as support GPS network strategy changes. The individual will also coordinate CMC submissions to ensure that BMS remains in compliance with the license application and minimize potential supply constraints.

Responsibilities

Represent regulatory CMCon and/or lead matrix teams

Independently provide strategic guidance/input related to current regulatory requirements and expectations for marketing applicationsand clinical trial applications for small molecule projects

Independently manage and prioritize multiple complex projects

Identify, communicate and propose resolutions to routine/complex issues

Review and provide regulatory assessments on 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 scientific discipline with 7-10+ years pharmaceutical industry experience - prefer multi-disciplined, 6+ years CMC regulatory strategy experience

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 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