Clora · 22 hours ago
Regulatory Affairs Consultant
United States
Contract
Remote
Senior Level
$35/hr - $235/hr
5+ years expClora is an AI startup focused on building specialized AI tools for complex life sciences workflows. They are seeking a regulatory affairs specialist to consult on CSR authoring and RFI handling, providing insights and feedback on workflows and product design.
Computer Software
Responsibilities
Participate in live working sessions with our team (e.g., video calls) to walk through current-state CSR and RFI workflows, answer detailed process questions, and provide real-time feedback as we design and refine AI-supported solutions
Share practical, end-to-end insight into how CSR authoring and RFI handling operate at large life sciences organizations, including stakeholders involved, handoffs, input materials, review cycles, timelines, and common pain points
Test and evaluate early versions of the product, providing candid feedback on workflow design, usability, accuracy, and regulatory fit to help guide feature prioritization and product direction
Provide asynchronous support as needed, including reviewing materials, responding to ad hoc questions, and offering targeted feedback between live sessions
Qualification
Required
Deep, hands-on experience (~5-10 years) across both CSR authoring and RFI management at large biopharma companies (ideally T10-20), with a strong understanding of how these workflows vary by development stage, indication, health authority, document type, and company context
Recent hands-on execution experience is required
Familiarity with real-world regulatory operating models at large life sciences organizations, including how processes evolve over time and differ across programs, regions, and teams rather than following a single 'textbook' approach
Able to think strategically about process design and improvement, identifying inefficiencies, bottlenecks, and opportunities to streamline workflows while maintaining regulatory rigor and quality
Comfortable engaging with emerging technology, with either direct experience using digital or AI-enabled tools in regulatory workflows or a clear interest in how technology can meaningfully improve how regulatory teams work
Strong communicator and collaborator, able to explain complex processes clearly, reason through edge cases, and provide thoughtful, constructive feedback in live discussions
Company
Clora
Clora is an intelligent platform that matches life science companies with flexible, on-demand expertise.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Rahul Chaturvedi
Founder/ CEO
Company data provided by crunchbase