(Senior) Regulatory Affairs Manager

vor 2 Wochen

Zug, Schweiz Viatris Vollzeit
Viatris Pharma GmbH

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.
 

Every day, we rise to the challenge to make a difference. As a (Senior) Regulatory Affairs Manager (m/f/d) , you will be responsible for managing new products submission and registered products lifecycle by preparing and submitting registration applications, variations, renewals, and label updates for the local affiliate.

Your responsibilities:

Timely submissions and execution of assigned products portfolio and other projects including full products lifecycle and new products submissions for Switzerland

lnteracting with various stakeholders on a local and regional level (Global Regulatory Affairs, Global Labelling, Quality, Supply Chain, Pharmacovigilance and Commercial) and the Regulatory Authority

Monitoring regulatory trends and provides strategic input to the management

Staying updated with local regulatory requirements and processes and the authority organization

Adhering to local processes and procedures to ensure clear regulatory responsibilities within the affiliate in line with Global SOPs and local regulations

Supporting both internal regulatory audits and Regulatory Authority inspections, and ensures that any corrective actions are completed according to schedule

Your profile:

Master’s Degree in life sciences

5 years of professional experience in Swiss Regulatory Affairs related to pharmaceutical products

Functional understanding of the pharmaceutical industry

Familiarity of local Swiss regulation for OTC products, Medical devices, cosmetics and food supplements and knowledge of regulatory requirements (e.g. revised Medical Device Ordinance / MDR) are benefits

Experience as PRRC is an advantage

Knowledge of the national and EU regulations, regulatory guidance, policies, and procedures

Good planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders

Excellent communication skills in German and English (written and oral)

What we offer you:

Friendly working atmosphere in a great team, Great Place to Work® certified office

Home office option up to 3 days per week

Development opportunities within an international company

At Viatris, we offercompetitivesalaries, benefitsandan 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.

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