RA CMC Officer
Peggy Buys
Business Unit Manager Production / L&D Coordinator
Job description
- 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
Profile
- 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