Regulatory submissions and health authority interactions
Experience with biologics and biosimilars
Cross-functional matrix team leadership
You will 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
You will formulate, lead, and drive global CMC/regulatory strategy, regulatory submissions, and health authority interactions for biosimilars and innovative products in a matrix organization.
We offer the opportunity to lead strategic regulatory projects for biosimilars and innovative products in a dynamic, international environment with experienced professionals.
At Rezon Bio, we believe in diversity and equality and encourage all individuals who meet the requirements to apply regardless of gender, age, orientation, or other individual characteristics.
Matching Summary
You will 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
regulatory submissions and health authority interactions
experience with biologics and biosimilars
cross-functional matrix team leadership
eCTD publishing and dossier compilation
knowledge of EU and US regulatory guidelines
project management under workload pressure
Nice-to-have
mentoring and coaching team members
collaborative culture and mentoring opportunities
professional proficiency in English
hands-on approach in matrix organizations
interaction with external partners and CMOs
Key Requirements
MSc or PhD in biotechnology, biochemistry, biology or equivalent
Over 7 years industry experience in regCMC area
Experience with CMOs, CROs, and external consultants
Deep knowledge of EMA and FDA regulatory procedures
Proven track record in clinical trial documentation and regulatory submissions