Drug Regulatory Affairs Coordinator (m/f)

REFERENZNUMMER:

297202/11

IHRE AUFGABEN:

-Provide timely preparation of high quality CMC regulatory documentation and contribute to global regulatory submissions and strategies under supervision
-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 and e-publishing requirements throughout project lifecycle
-Prepare CMC responses 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

IHRE QUALIFIKATIONEN:

-Advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
-Good knowledge of regulatory and/or experience in drug/biopharmaceuticals is benecifial
-Experience in contributing to timely global submissions/approvals through high quality documentation and data and adherence to regulatory requirements
-Knowledge of drug development processes are of advantage
-Excellent written/spoken communication and negotiation skills
-Fluency in English (oral and written), good German skills are beneficial

WEITERE QUALIFIKATIONEN:

Drug safety assistant