Location: Greater Basel, CH area (3 days remote)
Start Date: Aug/Sept
Duration: 3-6 months (with option to convert to perm)
Description: The client needs an experienced regulatory professional to prepare the registration and marketing authorization applications to SwissMedic. The team is an affiliate located in CH responsible for submitting the regulatory applications for the company’s generic (small molecules and biosimilars) and originator drugs (both small molecules and biologics). The team will get the module 3, 4 and 5 information and then compiles and prepares the module 1 components and filings with SwissMedic in German. Consultant must have German language capabilities and previous experience with SwissMedic understanding the regulations/requirements and what the agency expects to be included. Although the company may copy much of the information from original products, there are some differences in stability, shelf-life, dosage-forms, etc. that may require extra work.
Qualifications:
* Must have 5-10 years of relevant regulatory experience
* Experience with creation/editing of RA module 1 (admin information)
* Experience with SwissMedic
* Fluency in German
* Able to go on site 2 days per week
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Project Management
* Industries
Biotechnology Research and Medical Equipment Manufacturing
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