Back to jobsA Master’s or Bachelor’s degree in pharmaceutics, biomedicine, chemical engineering, or a related scientific field.
Over 8 years of experience in Regulatory Affairs, preferably within the CMC biologics area of the pharmaceutical or biopharmaceutical industry. Additional small molecules experience would be highly valuable.
Experience supporting combination products through development and approval.
Strong development experience including driving RA CMC strategic activities during development, including preparation for clinical trial submissions and global Health Authority interactions in anticipation of a marketing authorization application
Proven experience in preparing, submitting, and gaining approval for CMC/device documents across global markets.
Demonstrated ability to lead and manage complex regulatory projects effectively.
Extensive knowledge of global CMC guidelines and their application throughout development and the drug lifecycle.
Strong understanding of drug development processes, lifecycle management, and the strategic implications of scientific discussions on regulatory strategies.
Experience in cross-functional collaboration with RA, Product Supply, and Quality teams.
A strategic mindset with effective critical thinking, strong problem-solving, and risk mitigation skills.
Excellent communication, negotiation, and interpersonal abilities to align cross-functional teams and ensure effective decision-making.
Experience in development for rare diseases is an advantage.
