Description
We are looking for a
Regulatory CMC Associate Manager (m/f)
Reference: -en
Start: 10/17
Duration: 14 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- 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
Your qualifications
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Fluent English skills required (oral and written), good skills in site (local) language desired (oral)
- 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 of/experience with regulations, guidelines for NCEs and product life cycle maintenance desirable
Skills:
- Regulatory affairs assistant