Regulatory Strategist and Advisor - China Market, Client/Sponsor -Facing

Job Description

Remote

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Our client seeks a part-time Regulatory Strategist with deep China market expertise to advise emerging biotech sponsors on early clinical development. The advisor will shape regulatory strategy, inform clinical trial design and country selection for Phases I–II, and prepare teams for China-specific interactions and submissions. The role is client-facing and collaborative with internal teams to strengthen China regulatory advisory capabilities. This engagement is expected to start Spring 2026 for six months with potential extension.

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We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

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Rate: $100.00 to $150.00/hr. w2

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JN -042026-106542

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Responsibilities

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• Partner directly with small biotech sponsors to deliver strategic regulatory advice related to protocol development and trial planning in the China market.
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• Participate in client scoping sessions and clinical program discussions to identify optimal regulatory pathways and trial locations.
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• Advise on regulatory standards and landscape differences across key global regions, including comparisons between China, FDA, and EMA.
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• Support internal teams in building and refining China regulatory advisory capabilities, including development of content and client-specific briefings.
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• Contribute to early client engagements to demonstrate China regulatory expertise and enhance client experience.
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Experience Requirements

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• 15+ years of experience in Regulatory Affairs within pharma, biopharma, or biotechnology.
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• Deep knowledge of China regulatory frameworks and familiarity with differences from US/FDA and EU/EMA.
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• Proven regulatory strategy experience for clinical development, preferably supporting early-phase biotech programs, including CRO and country selection and trial strategy.
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• Strong client-facing communication and consulting skills with comfort engaging executives and study teams.
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