(Senior) Manager Regulatory Affairs (a)

• International Pharma Company
• Temporary contract with extension option

About Our Client

Our client is a biotechnology company in Basel that operates in the pharmaceutical industry, with a focus on the development and commercialization of innovative drugs in the areas of high unmet medical needs (oncology, immunology).

Job Description

Depending on the experience level of the candidate, the responsibilities are as follows:

• Coordinate the preparation, submission, management and maintenance of submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: CTAs, amendments and requests for information, Orphan drug applications, Paediatric Investigation Plans and Annual Reports
• Life cycle maintenance activities for marketed products including management information updates and assessment of promotional materials.
• Collaborate with key i...