For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role in their Regulatory Affairs department. This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment. This is a contract position 1 year initially.
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies throughout project lifecycle.
- 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 timeline
- Manage the continuous improvements to ensure compliance with HA requirements
The ideal candidate:
- Minimum Bachelor’s degree in the Healthcare & Life Sciences field
- Minimum 2 years' experience in Regulatory submissions
- Highly familiar with pharmaceutical technology and drug development process
- Fluent in English, German would be a great advantage
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to email@example.com.
We look forward to hearing from you!