Senior Scientist, Product Lead CMC Regulatory Affairs

Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities within Johnson & Johnson's Innovative Medicine R&D. Focuses on developing and implementing global CMC regulatory strategies for development and marketed biopharmaceuticals, primarily involving synthetic and novel modalities.

Responsibilities include integrating disease biology, pharmacology, and clinical data to inform strategy, preparing regulatory dossiers, supporting global filings, and representing CMC in cross-functional teams, including CMC and Regulatory Teams. The role involves regulatory submissions, compliance, and lifecycle management, including responding to health authority inquiries and supporting inspections.

Qualifications:

Bachelor's degree in a biological, chemical, pharmaceutical, or engineering science; at least 4 years of relevant industry experience, including drug development, analytical development, or manufacturing; knowledge of global regulatory laws and experience interacting with health authorities.

Preferred: advanced degrees (Master's, PharmD, Ph.D.), extensive experience with biologics or advanced modalities, and strong cross-functional communication skills.

High-Value: focus on innovative medicine, synthetic and new modalities, global regulatory strategy, and lifecycle management of development compounds and marketed products.

Work setup: hybrid in multiple U.S. locations, with a salary range of $109K-$174.8K.