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Regulatory Coordinator

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Hungary, Poland, Romania

Offer summary

Qualifications:

Post-Secondary Certificate, 1-3 years of related experience.

Key responsabilities:

Assist with clinical trial submissions
Maintain study regulatory trackers

Alimentiv SME https://alimentiv.com/

201 - 500 Employees

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Job description

Assist with and/or complete clinical trial submissions to Regulatory Authorities, Ethics Committees and other review bodies responsible for authorizing the conduct of clinical trials, ensuring compliance to ICH GCP, regional/local requirements. Submission support throughout the lifecycle of a clinical trial and timely tracking and filing of documents related to submissions and subsequent activities (e.g., approval, acknowledgements, correspondence, requests for information, etc.). Assist with continuous improvement initiatives within the department

Regulatory Study Lead

Regulatory study lead for studies that include one or two countries

Main point of contact for all regulatory related communications with the sponsor and internal study team

Review the study master Informed Consent Form

Author the Submission Management Plan with the support of senior regulatory team members

Author the Translation Requirements Plan if applicable to the study

Maintain study regulatory trackers and document sharing methods to communicate information to internal and external stakeholders

Participate in project team meetings as required, escalating complex regulatory discussions to senior regulatory team members

File documents to the TMF and perform routine file reviews as required

Regulatory Country Lead

Oversee and/or complete submissions to applicable regional review bodies throughout the lifecycle of the clinical trial to obtain and maintain regulatory approval/compliance status with the support of senior regulatory team members

Develop and/or author country-specific Informed Consent Forms in accordance with regional requirements

Working with senior team members, support the mitigation of identified regulatory risks

Oversee the development of and review site-specific Informed Consent Forms

Obtain translations to and from local language into English as defined in the Translation Requirements plan

Maintain study regulatory trackers to communicate information to internal and external stakeholders

Prepare response submissions to information requests in collaboration with key stakeholders

File documents to the TMF and perform routine file reviews as required

Process Improvements and Department Initiatives

Assist with ongoing department initiatives and objectives

Work with Line Manager to define personal goals that contribute to department improvement initiatives

Review and understand changes to key regulations and guidelines that impact the work of the Regulatory Affairs team

Qualifications