Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionThe Opportunity
This internship will give recent graduates the opportunity to learn and develop for one year while being part of our Regulatory affairs and quality department at Roche Diagnostics Cote d’Ivoire. During this internship you will have the opportunity to learn about our diagnosis solutions and while getting the chance to upskill while being part of impactful projects for our patients.
If you are curious to learn new things and want to kick off your career in one of the biggest pharmaceutical companies in the world this is your opportunity.
Regulatory Affairs Intern
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. Participes in the improvement of quality management system ,product complaints management, and distributors quality audit .
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 and maintenance 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
- Supports continuous improvement ( CAPA, review of processes, internal audits,external audit etc.)
- Ensures monitoring of reacto and materiovigilance
Who you are
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
You, as an ideal candidate, will have the following skills:
- Fluent 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
What will get out of this internship?
- Comprehensive professional experience that will allow you to acquire solid technical and practical knowledge in In vitro diagnostic.
- Regulatory ,quality & Soft skill training to be able to lead projects and provide sustainable value to patients in the VUCA ( volatility, uncertainty, complexity, and ambiguity) environment.
- You will have a mentor that will support your development throughout the internship.
Internship Duration: 1 year - Might be renewed for business needs
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.