Senior Manager Corporate Drug Regulatory Affairs (m/f/d)

at  Viatris

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. As a Senior Manager Corporate Drug Regulatory Affairs (m/f/d) you will be responsible for medicinal products and development projects.

Key responsibilities for this role include:

• Planning and organisation of the ressources (human and financial, i.e. budget)
• Regulatory advice to other departments of the company, as well as national subsidiaries, manufacturers and partners with special consideration of the pharmaceutical, pharmacological and scientific know-how
• Establishing national and international contacts with authorities
• Preparing and discussing regulatory strategies with national and international authorities
• Preparing and reviewing Standard Operation Procedures (SOPs)
• Identification and distribution of regulatory legal texts, guidelines, and other regulatory regulations
• Contact partner for audits
• Pharmaceutical-regulatory and scientific-regulatory assessment of license and acquisition offers (Due Diligence)
• Supervising and coordinating marketing authorisation application procedures worldwide, as well as registration maintenance (Life-Cycle-Management).
• Supporting and reviewing Periodic Safety Update Reports, Company Core Data Sheets, and Risk Management Plans for the medicinal products assigned to the team
• Education and training of pharmacists (AAppO and State Chamber of Pharmacists)

The minimum qualifications for this role are:

• Completed Master’s degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)
• 8 years of experience in regulatory affairs
• Governance of interdisciplinary projects including personnel management
• Leadership skills
• Knowledge of essential regulatory requirements globally
• Fluent in English and German language (written and oral)

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.

Key responsibilities for this role include:

• Planning and organisation of the ressources (human and financial, i.e. budget)
• Regulatory advice to other departments of the company, as well as national subsidiaries, manufacturers and partners with special consideration of the pharmaceutical, pharmacological and scientific know-how
• Establishing national and international contacts with authorities
• Preparing and discussing regulatory strategies with national and international authorities
• Preparing and reviewing Standard Operation Procedures (SOPs)
• Identification and distribution of regulatory legal texts, guidelines, and other regulatory regulations
• Contact partner for audits
• Pharmaceutical-regulatory and scientific-regulatory assessment of license and acquisition offers (Due Diligence)
• Supervising and coordinating marketing authorisation application procedures worldwide, as well as registration maintenance (Life-Cycle-Management).
• Supporting and reviewing Periodic Safety Update Reports, Company Core Data Sheets, and Risk Management Plans for the medicinal products assigned to the team
• Education and training of pharmacists (AAppO and State Chamber of Pharmacists

The minimum qualifications for this role are:

• Completed Master’s degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)
• 8 years of experience in regulatory affairs
• Governance of interdisciplinary projects including personnel management
• Leadership skills
• Knowledge of essential regulatory requirements globally
• Fluent in English and German language (written and oral