EU Regulatory Affairs Manager — Remote/Hybrid

Amgen SA; Greater London; Hybrid; GBP 70.000 - 110.000; Vollzeit

Zusammenfassung

Amgen seeks an EU Regulatory Affairs Manager to drive submissions for clinical trials and marketed products from a regulatory perspective within the EU region. The role involves developing strategies, providing guidance on regional mechanisms, and supporting label negotiations. Flexible to work from home with periodic presence in UK offices.

The candidate will contribute to regulatory strategy for products in development and lifecycle management, aligning with global plans and EU requirements.

Qualifikationen

• Degree educated with previous experience in a regulatory role.
• Experience with registration procedures (clinical trials, MA, post-approval changes).
• Experience developing regulatory strategies for products in development and post-marketing.
• Knowledge of EU legislation and regulations for medicinal products.
• Knowledge of policies, procedures and SOPs.
• Strong written and spoken communication skills.
• Ability to anticipate and prevent issues.
• Basic proficiency in using AI tools to support day-to-day work.

Aufgaben

• Plan and manage regulatory submissions for EU region.
• Provide regulatory guidance on regional mechanisms to optimize development.
• Support EU label negotiation activities.
• Develop regional regulatory product strategies.
• Stay aware of new legislation and regulatory guidance.

Kenntnisse

Regulatory strategy

Regulatory knowledge

Communication skills

Issue prevention

Conflict resolution

AI tools

Ausbildung

Bachelor's degree in life sciences

Tools

AI tools

Jobbeschreibung

Amgen seeks an EU Regulatory Affairs Manager to drive submissions for clinical trials and marketed products from a regulatory perspective within the EU region. The role involves developing strategies, providing guidance on regional mechanisms, and supporting label negotiations. Flexible to work from home with periodic presence in UK offices.

The candidate will contribute to regulatory strategy for products in development and lifecycle management, aligning with global plans and EU requirements.