Senior Regulatory Affairs Lead
Vor 3 Tagen
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/ start-up 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 non-interventional 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
- Great attention to detail
- Excellent English skills (written and spoken)
Linical is an equal opportunity employer.
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