Junior Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

316126/11

IHRE AUFGABEN:

-Under supervision, provide timely preparation of 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 and e-publishing requirements throughout project lifecycle
-Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
-Prepare CMC responses to health authority questions during development, registration and product lifecycle

IHRE QUALIFIKATIONEN:

-Degree in science (e.g. chemistry, pharmacy, biochemistry, biotechnology, biology) or equivalent
-Fluency in English required (oral and written), good skills in German language desired (oral)
-A solid experience in regulatory preferred, and/or experience in drug/biopharmaceuticals
-Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
-Knowledge of the drug development process desirable
-Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
-Reasonable approach to risk assessment

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager