Meda Pharma GmbH & Co KG

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. 
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. 

 

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. 

 

The Role & What You Will Be Doing 

Every day, we rise to the challenge to make a difference and here’s how the Corporate Drug Regulatory Affairs Manager - Scientific (m/f/d) role will make an impact: 

• handling of marketing authorisation application procedures (eg new submissions, line extensions,) worldwide, as well as registration maintenance activities (eg variations, renewals)

• review, preparation, coordination and processing of regulatory documents (CTD-module 1), quality documentation (CTD – module 3), with special consideration of biological-chemical aspects, including quality overall summaries (module 2.3)

• coordination of clinical and non-clinical documentation with clinical research, medical information and drug safety

• contact to authorites on national and international level

• preparation and discussion of licensing strategies with national and international authorities

• scientific-regulatory support and advice to other departments and business units before / during / after approval at national and international level

• support of QA activities (e.g. change control, PQR)

• support of drug information/ labelling acitivies

• support of pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)

• training of employees of the CDRA department according to the relevant professional knowledge

About Your Skills & Experience 

• completed university degree in natural sciences, i.e. Biology, Chemistry

• at least 3 years of experience in regulatory affairs

• knowledge of essential regulatory requirements globally

• ability to plan and execute regulatory projects with special consideration of the expertise acquired during education

• excellent communication skills, a real team player

• ability to establish working contacts with authorities

• excellent skills in English language

• knowledge in standard EDV programs (e.g. Word, Exel, Powerpoint)

What we offer you: 

• Independent work with a great team 

• A hybrid working model with one office day per week  

• Friendly working atmosphere with development opportunities 

This role is based in Bad Homburg, Germany near Frankfurt.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. 

 

Why Viatris? 

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. 

 

Diversity & Inclusion at Viatris 

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion  

 

Sustainability at Viatris 

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility  

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.