Remote Regulatory Strategist — Market; Biotech
Position: Remote Regulatory Strategist — China Market (Biotech) Regulatory Strategist and Advisor - China Market, Client/Sponsor -Facing Location: Anywhere (Remote) Type: Contract Industry: Life Sciences Reference - Date Posted: 04/22/2026
Job Description
Our client seeks a part‑time Regulatory Strategist with deep China market expertise to advise emerging biotech sponsors on early clinical development. The adviser 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. Compensation & Benefits Rate: $100.00 to $150.00/hr (W2). W2 employees are eligible for medical, dental, vision, 401(k) with match, and other benefits.
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.
Equal Opportunity Employment We are an Equal Opportunity and affirmative 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 (including pregnancy, childbirth, and related medical conditions), 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