Hobson Prior is seeking a dedicated Global and US Regulatory Lead to join a dedicated team. This position holds responsibility for guiding regulatory strategies and operational plans, particularly from a US perspective. The successful candidate will coordinate all aspects of regulatory submissions and serve as the primary interface with health authorities. This position requires a proactive approach to monitoring and evaluating the US regulatory environment to mitigate potential risks.
Please note, applicants must have legal authorization to work in the United States.
Responsibilities:
- Serve as the global and US regulatory lead for clinical development programs.
- Advise on regulatory strategies and operational plans from a US perspective.
- Coordinate all aspects of regulatory submissions, including developing and managing project timelines.
- Provide guidance on requirements for IND filings.
- Coordinate preparation and review of regulatory documentation such as INDs, IMPDs, clinical protocols, annual reports, labelling materials, meeting materials, briefing books, fast track and orphan drug designations, paediatric study plans, proposals for investigator-initiated trials, and responses to agency queries.
- Work with the regulatory operations group for the preparation and submission of health authority documents.
- Serve as the primary interface with health authorities.
- Participate as a regulatory representative in relevant teams, advising on regulatory strategies, submission preparation timelines, processes, and requirements.
- Monitor and evaluate the US regulatory affairs environment to maintain awareness of current and future risks that may impact the business.
Key Skills & Requirements:
- Degree in a scientific discipline.
- Comprehensive experience in US Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Experience managing submissions across all areas of regulatory affairs (CMC, Clinical, Non-Clinical).
- Oncology regulatory experience is highly desirable.
- Strong attention to detail with the ability to interpret complex information.
- Excellent written, presentation/oral communication, and customer service skills.
- Effective collaborator with the ability to build positive relationships with internal and external partners.
- Adaptable mindset capable of thriving in a dynamic, complex, and regulated environment.
For more information, please contact Syem Mannan.
Apply now
If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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