Regulatory Affairs and Back-up Safety Specialist Kosovo
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At Roche, 94,000 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. We do this today to build a better tomorrow. We are many, working as one across functions, across companies, and across the world.
On a mission to deliver better outcomes for more patients faster, we are looking for new member to join our team in the role of:
REGULATORY AFFAIRS AND BACK-UP SAFETY SPECIALIST KOSOVO
Key objectives of the role:
- Adapt global product dossiers to local requirements
- Prepare and manage regulatory registration filings across product lifecycles
- Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
- Ensure timely regulatory filings submissions and approvals
- Influence internal and external stakeholders for successful regulatory outcomes
- Manage Affiliate regulatory activities on relevant Roche systems
- Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
- Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
- Ensure regulatory compliance for products released to market according to marketing authorizations
- Medical degree / Pharmaceutical Degree
- Organization and planning skills
- Influencing skills
- Communication skills
- English language and Medical English —verbal and written
- Proven ability to interact well in a multifunctional team setting
- Experience and knowledge in working with agile methodologies
Location: Prishtina, Kosovo
Schedule: Full time
Job type: Temporary
Open until 14.02.2020.
Roche is an equal opportunity employer.
Doing now what patients need next.