Regulatory Affairs Intern

We are looking for 1 intern who wants to be part of our Medical Affairs & License to Operate chapter in the regulatory affairs department. The Regulatory Affairs intern performs the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies, SOPs, internal audits, and inspections. Compiles all materials required in submissions, license renewal, and annual registrations. Your main responsibilities:

• Analyze and communicate internal and external regulatory intelligence

• Provide regulatory input into cross-functional Affiliate business meeting

• Filing: Adapt global product dossiers to local requirements, prepare and manage regulatory registration filings across product life cycles, monitor and communicate all regulatory filing status

• Perform affiliate regulatory activities on relevant Roche systems

• Ensure regulatory inspection-readiness for the Affiliate

• Ensure regulatory compliance for products released to market according to marketing authorizations

• Review promotional and non-promotional material

You, as an ideal candidate, will have the following experience, education, and knowledge:

• Recent graduate with no more than 2 years of experience

• University Degree in Pharmacy / Medicine or other relevant Pharmaceutical or Biological Disciplines.

• Pharm D preferred

• Fluence in French

• Basic knowledge of English (written & spoken) with clear commitment on improving your language skills

• Eager to learn, self-managed & directed, bold, and being able to prioritize

• The ability to work with cross-functional teams is a must

• Ability to understand and leverage digital means and tools

• Ability to deeply listen, question & understand, and communicate smoothly