
Global Regulatory Strategist
1 day ago
We are seeking a skilled professional to fill the role of Global Regulatory Manager.
This position involves implementing regulatory strategy and managing operational activities for assigned regions. The successful candidate will provide input into global regulatory strategy, contribute to the development of the Regulatory Functional Plan (RFP), and identify gaps or risks in the global strategic plan for assigned regions.
The ideal candidate will partner with regions to align on regulatory strategy and implement the RFP across assigned regions. They will determine requirements and set objectives for Health Authority (HA) interactions, facilitate the preparation and finalization of briefing books, and contribute to the preparation of summary documents.
Key responsibilities include developing and implementing plans for timely response to HA requests, coordinating responses, and serving as local HA liaison when necessary. The successful candidate will also drive coordination, planning, and submission of dossiers in assigned regions worldwide, review global dossier summary documents, and develop plans to avoid/minimize clock stops during submission review.
In addition, the Global Regulatory Manager will be responsible for reviewing, approving, and submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), as well as reviewing and submitting Risk Management Plans. This role may involve leading negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
Main Accountabilities:
- Implement regulatory strategy and manage operational activities for assigned regions
- Contribute to the development of the Regulatory Functional Plan (RFP)
- Partner with regions to align on regulatory strategy
- Determine requirements and set objectives for Health Authority (HA) interactions
- Facilitate the preparation and finalization of briefing books
- Review global dossier summary documents
- Develop and implement plans for timely response to HA requests
Required Skills and Qualifications
To succeed in this role, you will need:
- Clinical Trials expertise
- Detail-Oriented approach
- Strong understanding of Drug Development principles
- Lifesciences background
- Negotiation Skills
- Regulatory Compliance knowledge
- Excellent communication and project management skills
Benefits
This role offers a challenging and rewarding opportunity to work in a dynamic industry and make a meaningful contribution to our organization's success.
Skillset: Regulatory Compliance
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