Regulatory Specialist - Submission Coordinator - Secondment
Regulatory Specialist - Submission Coordinator - Secondment
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Job Description
Regulatory Affairs Management: Accountable for the organisation s awareness of regulatory frameworks and relationships with regulatory authorities/bodies relating to innovation development product delivery (e.g. registration/promotion) and life-cycle maintenance (CMC/Clinical/Labeling updates renewals recalls: maintains license to operate). Ensures awareness of current standards to direct R&D and Commercial on requirements to ensure compliance. Develops/executes strategies to ensure data & document provision/submission in accordance with specific market regulator requirements. Drives process improvements to increase efficiencies. Engages and advances organization positions with internal and external parties. Job Family - Regulatory Affairs Management: Accountable for the organisation s awareness of regulatory frameworks and relationships with regulatory authorities/bodies relating to innovation development product delivery (e.g. registration/promotion) and life-cycle maintenance (CMC/Clinical/Labeling updates renewals recalls: maintains license to operate). Ensures awareness of current standards to direct R&D and Commercial on requirements to ensure compliance.
Remote Work :
No
Employment Type
Full Time
