Regulatory Operations Specialist
Responsible for BLA/MAA delivery and life cycle management working within Global Technical Operations. Provide submission related expertise. Lead the process of critical review of regulatory documents and incorporating multiple internal and external reviews into quality documents. Manage SM activities associated with multiple projects: delivery of documents to submission ready standards. Participate or lead template and procedure preparations. Participate in SM-related workstreams within and across departments. Assists in providing ANGEL business support and training to BioOperations network. Lead or participate in process improvement initiatives. Work with Reg CMC, BPD Submission Management ensure seamless transfer of submission management responsibilities for post approval submissions and Wave 2+ markets.
Experience in pharma industry
Experience with regulatory submissions, eCTD, submission ready standards
CMC and post-approval lifecycle document management a plus
Time Management
Record Keeping Skills
Document Management Systems
Process Improvement
Verbal communication
written communication
Self-Driven
Multi-tasker
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Kelly Services, Inc. is an American office staffing company that operates globally. The company places employees at all levels in various sectors including financial services, information technology, and law.
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