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Provide
timely preparation high quality CMC regulatory documentation and support to
contribute to global regulatory submissions and strategies.
Author high- quality CMC documentation for HA submission, with
support and guidance, applying agreed CMC global regulatory strategies,
assuring technical congruency and regulatory compliance, meeting agreed upon
timelines.
Prepare CMC response to health authority questions during
development, registration and product lifecycle
Identify the required documentation for global submissions and
negotiate the delivery of approved technical source documents in accordance
with project timelines.
Identify content, quality and/or timelines issues with source
document
Keep knowledge up to date with regard to regulatory guidelines
Jouw profiel
Master degree in Science (e.g
Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent or PhD
Dutch, English fluent / oral and
written
Regulatory experience preferred, and/or
experience in drug/biopharmaceutical
Working knowledge of
chemistry/biotechnology, analytics or pharmaceutical technology.
Ability to critically evaluate data
from a broad range of scientific disciplines
Knowledge of regulatiions, guidelines
for NCE’s and product life cycle maintenances is a plus
Ability to work successfully with
extended, multinational project team on multiple projects
Excellent planning, organizational and
interpersonal skills
Excellent written/ spoken communication
and negotiation skills