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

$100 - $150 per hour

Eliassen Group

Regulatory Strategist and Advisor - China Market, Client/Sponsor -Facing Location: Anywhere. Type: Contract. Category: Q&R. Industry: Life Sciences. Workplace Type: Remote. Reference ID: JN -042026-106542. Date Posted: 04/22/2026. Remote. 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. Rate: $100.00 to $150.00/hr. (W2) Responsibilities Partner directly with small biotech sponsors to deliver strategic regulatory advice related to protocol development and trial planning in the China market. Participate in client scoping sessions and clinical program discussions to identify optimal regulatory pathways and trial locations. Advise on regulatory standards and landscape differences across key global regions, including comparisons between China, FDA, and EMA. Support internal teams in building and refining China regulatory advisory capabilities, including development of content and client‑specific briefings. Contribute to early client engagements to demonstrate China regulatory expertise and enhance client experience. Experience Requirements 15+ years of experience in Regulatory Affairs within pharma, biopharma, or biotechnology. Deep knowledge of China regulatory frameworks and familiarity with differences from US/FDA and EU/EMA. Proven regulatory strategy experience for clinical development, preferably supporting early‑phase biotech programs, including CRO and country selection and trial strategy. Strong client‑facing communication and consulting skills with comfort engaging executives and study teams. Benefits W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for medical (choice of 3 plans), dental, vision, pre‑tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked‑in state/locality. Additional benefits include Medical, Dental, and Vision benefits, 401k with company matching, and life insurance for hourly consultants. Equal Employment Opportunity Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affluent Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex, marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, or any other category protected by federal, state, or local laws. #J-18808-Ljbffr Eliassen Group

Vacancy posted 5 days ago
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