CDRA Manager Pharmaceutical (m/f/d)

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. 

Every day, we rise to the challenge to make a difference. Every day, we rise to the challenge to make a difference, and here’s how the role CDRA Manager Pharmaceutical (m/f/d) will make an impact:

Key responsibilities for this role include:

• examination, preparation, coordination, and processing of regulatory documents
• pharmaceutical quality documentation (CTD – module 3),
• pharmaceutical development
• manufacturing and quality control
• pharmaceutical technology
• pharmacological-toxicological documentation
• as well as pharmaceutical expert reports,
• risk-benefit-description for medicinal products with regard to pharmaceutical pharmacological topics
• coordination of clinical and non-clinical documentation with clinical research, medical information, and drug safety
• handling of marketing authorization application procedures (new submissions, line extensions, variations) worldwide, as well as registration maintenance activities (eg variations, renewals)
• contact to authorities on national and international level
• preparation and discussion of licensing strategies with national and international authorities
• pharmaceutical-regulatory support and advice to other departments and business units (e.g. of the Qualified Person acc. § 15 German Drug law) regarding pharmaceutical topics before / during / after approval at national and international level
• support of QA activities (e.g. change control, PQR)
• support of drug information/ labelling activities
• support of pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)
• training of employees of the CDRA department with regard to pharmaceutical topics
• participation in the training and education of pharmacists (e.g. pharmacy students in the context of the third training section according to AAppO)

The minimum qualifications for this role are:

• completed university degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)). A detailed description of the know-how acquired during the studies in pharmacy can be found in Appendix 1 to § 2 (2) AAppO
• 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 pharmaceutical and pharmacological know-how
• 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, Excel, PowerPoint).

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.

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