Formulate, lead, and drive global CMC/regulatory strategy, regulatory submissions, and health authority interactions for biosimilars and innovative products in a matrix organization
Job Summary
Formulate, lead, and drive global CMC/regulatory strategy, regulatory submissions, and health authority interactions for biosimilars and innovative products in a matrix organization.
Provide strategic regCMC and medical device input to development projects and guide interdisciplinary teams in preparing high-quality documents for regulatory submissions.
Opportunity to lead strategic regulatory projects for biosimilars and innovative products in a dynamic, international environment with experienced professionals.
Matching Summary
Formulate, lead, and drive global CMC/regulatory strategy, regulatory submissions, and health authority interactions for biosimilars and innovative products in a matrix organization.
Skills & Requirements
Must-have
global CMC/regulatory strategy
regulatory submissions
health authority interactions
biosimilars and innovative products
medical device input
eCTD publishing
EU and US regulatory guidelines
Nice-to-have
hands-on approach
collaborative culture
mentoring opportunities
diversity and equality
Key Requirements
MSc or PhD in biotechnology, biochemistry, biology, or equivalent
Over 7 years of industry experience in regCMC
Experience working with CMOs, CROs, and external consultants