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
- Minimum of Post-Secondary Certificate +1-3 years of related experience.
- Life sciences specialty and/or Regulatory designation is preferred.
- Attention to detail.
- Flexible and adaptable.
- Basic understanding of the regulatory submission requirements for clinical trials (regional-focus).
- Basic understanding of ICH-GCP.
- Resourceful; i.e., ability to source regulatory requirements in the public domain or the Regulatory Intelligence platforms.
- Proficient in Microsoft-based systems: Word, Excel, PowerPoint.
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Last updated on Jan 7, 2025