Regulatory Consultant

ResponsibilitiesGlobal Regulatory Strategy

• Support the development and execution of the global regulatory strategy for the assigned investigational drug. * Identify regulatory opportunities, risks and key strategic considerations throughout early clinical development.
• Provide regulatory recommendations to support clinical development plans and key program decisions. * Ensure alignment of regulatory strategy with the broader clinical and development objectives for the asset.
• Support planning for the program's transition from early development into the late-stage regulatory organization around Phase 1b/Phase 2. FDA and EMA Regulatory Leadership
• Provide strategic guidance regarding FDA and EMA regulatory requirements and expectations.* Support preparation for health authority meetings, scientific advice and other regulatory interactions.
• Contribute to briefing documents, regulatory questions, responses and meeting strategy. * Translate health authority feedback into clear recommendations and regulatory actions for the development team.

Early Clinical Development * Provide regulatory leadership for activities supporting Phase 1 through Phase 1b/Phase 2 development.

• Advise on regulatory considerations affecting clinical development plans, study design and development milestones. * Support IND and CTA activities, including ongoing regulatory maintenance and development-related submissions.
• Identify regulatory issues that could affect development timelines or future global submission strategy. Cross-Functional Leadership
• Partner closely with regulatory, clinical/medical, safety, CMC and other development functions as appropriate. * Participate in relevant cross-functional development team discussions.
• Ensure regulatory considerations are incorporated into key development decisions. * Build alignment across stakeholders while working within the direction and governance established by the client's Early Development Regulatory team.

Regulatory Deliverables and Execution * Lead or support preparation and review of key regulatory documents and deliverables.

• Ensure regulatory activities are consistent with the agreed global strategy. * Provide strategic review and regulatory input into development documentation.
• Support seamless knowledge transfer and regulatory transition as the asset progresses toward Phase 2.