
Global Regulatory Operations Manager
2 days ago
Job Summary
\We are seeking a skilled professional to join our team as an Associate Global Program Regulatory Manager. The ideal candidate will have experience in implementing regulatory strategies and managing operational activities.
\Main Accountabilities:
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- Develop and implement global regulatory strategies for timely submissions and approvals.\
- Partner with regions to align on regulatory strategy and ensure business objectives are met.\
- Determine requirements and set objectives for Health Authority interactions.\
- Facilitate preparation and finalization of briefing books and contribute to summary documents.\
- Develop and implement plans for timely response to HA requests and coordinate responses.\
- May serve as local HA liaison depending on location.\
- Drive coordination, planning, and submission of dossiers worldwide.\
- Review global dossier summary documents.\
- Develop and implement plans to avoid/minimize clock stops during submission review.\
- Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).\
- Reviews and submits Risk Management Plans.\
- May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.\
- Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.\
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