Corporate Drug Regulatory Affairs Manager

vor 2 Monaten

Bad Homburg, Deutschland Viatris Vollzeit
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, and here’s how the role Corporate Drug Regulatory Affairs Manager - Pharmaceutical (m/f/d) will make an impact:

Your key responsibilities:

Examine, prepare, coordinate, and process regulatory documents

Manage pharmaceutical quality documentation (CTD – module 3), development, manufacturing, and quality control

Handle pharmaceutical technology and pharmacological-toxicological documentation

Develop pharmaceutical expert reports and risk-benefit descriptions for medicinal products

Coordinate clinical and non-clinical documentation with relevant departments

Oversee global marketing authorization procedures and registration maintenance

Liaise with national and international authorities, preparing and discussing licensing strategies

Provide pharmaceutical-regulatory support and advice to various departments

Support QA activities and pharmacovigilance-related tasks

Train CDRA department employees on pharmaceutical topics

Participate in the training of pharmacists and pharmacy students

Who you are:

University degree in pharmacy as per AAppO regulations

At least 3 years of experience in regulatory affairs

Knowledge of global regulatory requirements

Strong planning and execution skills for regulatory projects

Excellent communication skills and a team player mentality

Proficiency in establishing contacts with authorities

Excellent English language skills

Proficiency in standard office programs (Word, Excel, PowerPoint)​

This role is based in Bad Homburg, Germany near Frankfurt. There is a hybrid working model with one office day per week.

Join us and make an impact in the pharmaceutical world

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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