Mark Charest, MS, RAC

* Led regulatory strategy across six marketed products and lifecycle initiatives, including FDA Type A, B, C, and D interactions. * Provided executive-level guidance on regulatory risks, timelines, agency strategy, and portfolio priorities. * Oversaw NDAs, INDs, REMS, PMRs, labeling commitments, and internal governance systems. * Built scalable regulatory operations through workflow modernization, publishing centralization, and process improvements. * Directed external consultants, vendors, and cross-functional stakeholders to deliver complex regulatory priorities. * Supported Commercial, Medical, and Legal teams on labeling, promotional, and market execution matters.

* Served as Regulatory Affairs lead for long-acting oral schizophrenia program, including a successful End-of-Phase 2 FDA meeting supporting pivotal development strategy and 505(b)(2) pathway considerations. * Led engagement with FDA’s Emerging Technology Team supporting advanced manufacturing strategy, process analytical technology (PAT), and real-time release testing concepts. * Directed global regulatory strategy for a Gates Foundation-supported malaria vector-control program, including EMA Scientific Advice supporting WHO prequalification pathway. * Conducted regulatory due diligence to support financing rounds, program readiness assessments, and development risk evaluation. * Managed cross-functional regulatory planning across clinical, CMC, nonclinical, and manufacturing stakeholders. * Supervised and mentored regulatory staff on authoring support, regulatory intelligence, and strategic planning.

* Led regulatory strategy for Phase 2–3 gastrointestinal development programs, partnering closely with FDA on clinical development plans, endpoints, patient population, claims support, and post-market safety strategy. * Served as primary regulatory liaison with FDA for formal and informal communications, including briefing documents, meeting materials, and agency responses. * Led cross-functional labeling team to develop prescribing information aligned with clinical endpoints, lifecycle goals, and commercial differentiation strategy. * Supported sNDA prescribing information updates for Linzess® and authored alternative administration labeling language. * Directed European regulatory interactions, including BfArM Scientific Advice, shaping development strategy, endpoints, and patient-reported outcome framework. * Implemented eCTD submission management systems in partnership with Regulatory Operations and IT, including testing, workflows, training, and adoption.

* Served as Regulatory Affairs lead for NDA submission activities, coordinating eCTD publishing vendors, clinical summaries, CMC Module 3 content, and regional Module 1 components. * Directed cross-functional review of summary documents and key reports, managing quality review cycles to meet submission timelines. * Managed completion of legacy clinical study reports in partnership with CRO medical writers to support NDA readiness. * Supported Advisory Committee preparation, including expert outreach, briefing materials, planning sessions, and strategic feedback integration. * Led simultaneous global regulatory initiatives including EMA Scientific Advice, EMA Orphan Application, FDA Orphan Application, and IND planning for U.S. and EU development programs. * Developed eCTD templates in alignment with ICH M4 guidance for the company’s first electronic IND submission.

* Supported NDA submission readiness by coordinating finalization of nonclinical and clinical summary components and key pre-NDA deliverables. * Contributed to co-development governance activities, cross-functional planning, and partner coordination to maintain program timelines. * Provided guidance to functional authors using ISI Writer eCTD software and supported document quality for submission publishing. * Assisted regulatory teams with document tracking, review coordination, and preparation of submission-ready materials.

* Authored multiple IND submissions supporting iontophoretic drug delivery programs in herpes labialis and onychomycosis advancing into Phase 1 and Phase 2 development. * Supported combination product regulatory strategy across drug-device development programs, including submission planning and health authority requirements. * Evaluated 14+ eCTD publishing vendors, established selection criteria, and recommended implementation of electronic submission capabilities. * Reviewed protocols, informed consent forms, safety reports, and site activation documentation supporting compliant clinical trial start-up. * Coordinated cross-functional activities with clinical, CMC, and technical teams to maintain regulatory timelines and submission readiness.

* Supported pharmacovigilance and clinical drug safety operations for marketed and development-stage products, ensuring timely processing and documentation of safety information. * Reviewed adverse event reports, case narratives, and source documentation for completeness, accuracy, and regulatory compliance. * Assisted preparation of safety reports, line listings, and supporting documentation for internal review and regulatory submissions. * Coordinated cross-functional follow-up with Clinical, Medical, and Regulatory teams to obtain and reconcile safety data. * Maintained safety databases, documentation systems, and inspection-ready records in accordance with company procedures and regulatory requirements.

• Maintained a web based documentation system for high throughput processes accessed by over 100 employees in Molecular Research Services (MRS).