Senior Scientist, Regulatory CMC Biologics Full-time NEW

Senior Scientist, Regulatory CMC Biologics

Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.

Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.

Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems.

Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed

Conduct all activities with an unwavering focus on compliance

Education Minimum Requirement:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Required Experience and Skills:

• 5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field.

Preferred Experience and Skills:

• Experience in biologics Regulatory CMC preferred.

Required Skills:

Business Processes, CMC Documentation, CMC Strategy, Detail-Oriented, Document Coordination, Drug Product Development, Interpersonal Relationships, Pharmaceutical Products, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Interpretation, Regulatory Project Management, Regulatory Strategy Development, Writing Technical Documents

Preferred Skills:

CMC Biologics