Duties and responsibilities:

• Prepare, compile, and submit regulatory documentation for product registration, renewals, and variations in accordance with Swissmedic, EMA, and FDA requirements.
  
• Ensure ongoing compliance of product dossiers with relevant pharmaceutical regulations and internal quality standards.
  
• Monitor and interpret regulatory changes at local and global levels, assessing their impact on company operations and products.
  
• Support cross-functional teams (Quality Assurance, R&D, Manufacturing, Supply Chain) in regulatory aspects throughout the product lifecycle.
  
• Maintain up-to-date knowledge of pharmaceutical legislation, guidelines, and best practices.
  
• Liaise with health authorities and regulatory agencies as needed.
  
• Contribute to internal audits and regulatory inspections.

The ideal candidate will have the following skills, knowledges and experience:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
•  2–3 years of experience in Regulatory Affairs within the pharmaceutical industry, gained in Switzerland
• Solid knowledge of EU and Swiss pharmaceutical regulations (Swissmedic, EMA, FDA knowledge is an asset).
• Experience in preparing and maintaining CTD/eCTD dossiers.
• Strong communication and organizational skills with excellent attention to detail.
• Fluent in English (written and spoken); Italian and/or German is a plus.
• Ability to work independently and collaboratively in a fast-paced environment.