Regulatory Affairs Specialist (1 year fixed-term contract)

At VIATRIS™, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access – Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
• Partnership – Leveraging our collective expertise to connect people to products and services. 
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Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact: 

Key responsibilities for this role include:

• Support Viatris medicinal products registration in Serbia, Montenegro and North Macedonia
• Prepare dossier for the registration, variation or renewal application of medicinal products
• Management of all issues with regard to re-registrations/renewals of products
• Management and update all internally required reporting activity
• Ensure compliance to all relevant regulatory legislation and internal procedures
• Liaising with external authorities & trade organizations for insights into current activity
• Act as back-up of Quality Responsible Person: Implement, maintain and manage quality systems and compliance related activities
• Takeover the responsibility of the ASR for legal entity PV system (responsible for Serbia, Macedonia and Montenegro) during the absence of ASR

The minimum qualifications for this role are: 

• University degree in Pharmaceutical Faculty
• Minimum 2 years of experience in Regulatory Affairs is required
• Good knowledge and understanding of local HA requirements/lows, global SOPs
• Confident user skills in Microsoft Office applications
• Excellent communication and problem-solving skills
• Ability to work independently
• Ability to prioritize
• Proficiency in speaking, comprehending, reading, and writing English is required

To apply for this position, please send your CV in English language as well. 

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.