Viatris CZ s.r.o.

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. 
 

SUMMARY OF ROLE

• Regulatory support to all Viatris Marketing authorizations of drug products and post-authorization procedures and activities related to product lifecycle.
• Regulatory support of assigned Viatris products - authorizations and post-authorization procedures.
• Gaining regulatory authority approval for marketing authorizations and post-authorization submissions. Cooperate and support other departments if required (Marketing, Portfolio management, PV, Supply chain, Quality,) to secure registration issuance and maintenance and availability of products to local market.

KEY RESPONSIBILITIES AND FUNCTION

Briefly describe the essential activities that are performed by the role, including key supervisory duties/responsibilities. Each statement should begin with a verb.

INDIVIDUAL

• Prepare locally required documents for submission and procedures of new MAA, variations to MA, renewal, and other regulatory procedures (including the application forms, declarations, national version of product information texts, responses to questions, payments, cover letters, refunds, AW requests etc) within the requested deadlines.
• Implement local regulatory strategies for national and MRP/DCP procedures
• Ensure regulatory compliance within all product portfolio and sufficient knowledge of national law and guidelines, as well as European directives, and their effect to all processes.
• Negotiate with local Authorities, support HQ requests.
• Maintain regular communication and to update manager on any new developments at local level that may impact product lifecycle
• Ensure data bases are up to date (Trackwise, D2, MyPortfolio, RIM, FPR, any other applicable)   
• Liaise with health authorities, corporate head-office registration/regulatory issues
• Take part in relevant trainings and seminars
• Ensure text translations, artwork creation, verification and approval
• Liaise with manufacturing sites, corporate head-office and affiliate departments on registration/regulatory issues

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. 

Viatris is an Equal Opportunity Employer.