
Regulatory Affairs Specialist
1 dia atrás
This role involves overseeing the regulatory affairs function, ensuring compliance with relevant organizational and regulatory SOPs and WPDs.
Key Responsibilities:- Submission Oversight: Oversee all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions, and ensure adherence to standard RAL procedures applicable to EC and RA submissions.
- Document Development: Develop, translate, and file country and site-specific submission-related documents for RA, US IRBs and Canadian ECs submissions, and inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.
- Team Collaboration: Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.
- Strategic Planning: Oversee the development of strategic plans for regulatory submissions, ensuring alignment with business objectives.
- Process Improvement: Identify areas for process improvement and implement changes to enhance efficiency and effectiveness.
This position requires a strong understanding of regulatory affairs principles and practices, as well as excellent communication and project management skills. The ideal candidate will be able to work effectively in a matrix environment and collaborate with cross-functional teams.
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