Senior Regulatory CMC Manager
Posted on Apr 15, 2022 by RM IT Professional Resources AG
Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Creating high-quality CMC documentation for HA submission as well as applying agreed CMC global regulatory strategies
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Determining the required documentation for global submissions and negotiating the delivery of approved technical source documents
- Identifying issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
- Performing activities in support of the general department such as annual and product renewal writing, coordination of source documentation and other database entry activities
- Establishing and maintaining sound working relationships with partners and customers
- Knowledge of chemistry, biotechnology, analytics or pharmaceutical technology
- Well-versed with critically evaluating data from a broad range of scientific disciplines
- Regulatory experience or expertise in drug or biopharmaceuticals is desirable
- Knowhow of regulations, guidelines for NCEs and product life cycle maintenance is a plus
- Degree in Science like Chemistry, Pharmacy, Biochemistry or Biology or equivalent
- English, fluent in written and spoken
Your soft skills:
- Excellent planning and communication skills along with a reasonable approach to risk assessment
- Ability to work with extended project teams and coordinate activities simultaneously on multiple projects
Location: Basel, Switzerland
Duration: 8 months with an option for extension
Take the next step and send us your CV and contact phone number on which we can reach you during working hours.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are welcome, we will support you all the way.
By applying, you agree to the storage and processing of your data for the application process. We strictly comply with the applicable data protection laws.