|
Drug Regulatory Dr Work is to Timely preparation of high quality drug substance and if required drug product Quality documentation to support global regulatory submissions.
Write high-quality CMC documentation for marketed products, obtaining rapid and advantageous registrations of change, or for routine maintenance such as renewals, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
Prepare CMC responses to health authority questions, during development, registration, and product lifecycle.
Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
|
