Senior Regulatory Affairs Lead - Munich, Deutschland - Linical Europe

Linical Europe

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Linical Co., Ltd.

('Linical') is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development.

With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Linical's European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.

As a Senior Regulatory Affairs Lead you will:

Main duties:

Coordinates and manages a pool of RAOs, contracted vendor Regulatory Affairs personnel, and Linical CRAs (when no local RAO available) within a project team
Coordinates the submission to Ethics Committees (central and local) and to Competent Authorities in different countries.
Provides expert regulatory advice and contributes to regulatory project work.
Develops, collects, and customizes core submission documents.
Ensures that regulatory timelines are met through effective project regulatory management.
Provides leadership in the delivery of regulatory services to Sponsors, ensures that regulatory team fulfil their responsibilities in accordance with Linical procedures and SOPs.
Reviews project regulatory status on an ongoing basis and intervenes where necessary to identify high risk areas and to anticipate/resolve project related issues.
Provides regular status reports as agreed
Ensures quality control checks are performed on the content of central submission packages.
Contributes to the creation, implementation and ongoing review of the Regulatory methodology and internal tools and processes.
Supporting Business Development opportunities by providing regulatory input on proposals and budgets, attends bid defence meetings and capabilities meetings.

Education & Experience:

University/college degree (Master's or other advanced degree is preferred) with strong professional experience across regulatory/ startup activities within a CRO, biopharmaceutical company or relevant clinical environment
International experience with complex regulatory project management is required.
A general knowledge of the clinical trial and noninterventional study process and CRO industry is mandatory for this function.

Additional skills:

A great team player, with the ability to work independently in an international environment
Effective time management and excellent organisational skills
Excellent communication and inter

- personal skills