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Country Regulatory Compliance Specialist

2 meses atrás

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**Job Summary**

Thermo Fisher Scientific is seeking a highly skilled Country Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing local regulatory strategy advice to internal clients, coordinating project-specific local SIA services, and ensuring alignment of submission process for sites and study with the critical path for site activation.

**Key Responsibilities**

• Provide local regulatory strategy advice to internal clients, ensuring compliance with relevant regulations and guidelines.

• Coordinate project-specific local SIA services, including feasibility activities and trial status information.

• Ensure alignment of submission process for sites and study with the critical path for site activation.

• Achieve PPD's target cycle times for site activation.

• Develop country-specific Patient Information Sheet/Informed Consent form documents.

• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

**Requirements**

• Bachelor's degree in a relevant field, such as life sciences or regulatory affairs.

• Proven experience in regulatory affairs, with a focus on country-specific compliance.

• Strong knowledge of local regulations and guidelines, including MoH and EC requirements.

• Excellent communication and project management skills.

• Ability to work independently and as part of a team.