Remote Biotech research and development Jobs · Regulatory Affairs

Job listings

$330,000–$350,000/yr

  • Lead and scale the Clinical Operations function for MiraVi's ophthalmology programs.
  • Drive global clinical operations strategy, CRO/vendor oversight, and study execution from startup to close-out.
  • Partner with regulatory, CMC, quality, and finance to deliver compliant, on-time, on-budget trials.

MiraVi is an ophthalmology affiliate of Osanni focused on advancing treatments for dry age-related macular degeneration (AMD). The company is building a highly skilled, collaborative team dedicated to developing new medicines for patients.

$375,000–$400,000/yr
US Unlimited PTO

  • Provide strategic leadership and operational oversight for clinical trial design, analysis, and reporting.
  • Build and mentor a high-performing clinical biostatistics team while driving regulatory submissions.
  • Partner with cross-functional teams and vendors to ensure high-quality statistical and data management support.

Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than industry standard. With over $845M in total funding and a $2B valuation, the company is recognized as a top startup employer and has three oral medicines in the clinic.

  • Define and oversee Toxicology and Non-Clinical Pharmacology strategies for assigned projects.
  • Serve as the subject matter expert in Toxicology, managing preclinical safety studies and regulatory interactions.
  • Ensure translational aspects and safety alerts are integrated into benefit/risk assessments.

A biopharmaceutical company dedicated to developing innovative therapies for rare diseases. With over 1,900 employees in more than 30 countries, Sobi fosters a culture of inclusion and empowerment.

  • Lead the clinical development of respiratory disease programs, overseeing study design, execution, and delivery across the development lifecycle.
  • Provide scientific oversight to ensure patient safety, study quality, and timely delivery while generating and interpreting clinical evidence.
  • Collaborate with cross-functional teams and external stakeholders to align clinical strategies with regulatory, commercial, and patient needs.

They are a pharmaceutical company focused on advancing clinical research and developing innovative treatments for respiratory diseases. The organization fosters an inclusive, collaborative culture that prioritizes patient impact, professional growth, and scientific innovation.

US Unlimited PTO

  • Drive and execute clinical research and real-world evidence across the product portfolio.
  • Design protocols, statistical analysis plans, and support regulatory activities.
  • Generate evidence for product development, reimbursement, and scientific dissemination.

Sequel develops next-generation drug-delivery technology, starting with the twiist Automated Insulin Delivery (AID) System for diabetes management. The company fosters a culture of hard work, fun, and genuine support, with a strong focus on employee well-being and comprehensive benefits.

US Unlimited PTO

  • Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
  • Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
  • Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.

Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.