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Regulatory Affairs and Back-up Safety Specialist Kosovo

Regulatory Affairs and Back-up Safety Specialist Kosovo

Information

Publish Date

29.01.2020

End Date

14.02.2020

Categories

Të tjera...

Job Places

Prishtinë

Job Description

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

Education /Qualifications:

  • 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

Additional details:

Location: Prishtina, Kosovo
Function: Regulatory
Schedule: Full time
Job type: Temporary
Open until 14.02.2020.

Roche is an equal opportunity employer.
Doing now what patients need next.

Apply Here

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