Jeanne L.

Independent consulting and management practice (name withheld) providing senior-level advisory services in regulatory, quality, clinical and operational strategy to life‑science and healthcare organizations.

• Provided executive consulting and interim management services across regulatory, quality and clinical functions for small-to-mid sized life‑science clients.
• Developed regulatory strategies and submission roadmaps (US, EU and other key markets) to accelerate product development and market entry.
• Designed and implemented quality management system improvements (policy, procedures, CAPA, supplier management) to support compliance and inspections readiness.
• Coached and mentored cross‑functional teams (R&D, manufacturing, clinical, commercial) to improve product launch execution and risk management.
• Managed client relationships and business development activities, including proposals, project scoping and delivery of technical training and regulatory workshops.

Next Science Limited (Next Science) is a medical technology company focused on biofilm‑disrupting technologies and advanced wound and surgical care products (e.g., XPERIENCE, BLASTX, SURGX) with commercial operations in the U.S.

• Led global regulatory affairs, quality assurance and clinical operations functions supporting commercial launches of surgical and wound‑care products powered by XBIO technology.
• Directed regulatory strategy and prepared regulatory submissions and technical dossiers for multiple markets (including FDA and other authorities); coordinated responses to regulatory questions and audits.
• Owned the Quality Management System (ISO 13485/FDA QSR alignment), vendor qualification, CAPA and change control processes to ensure post‑market compliance and inspection readiness.
• Oversaw clinical operations and study design for investigator‑led and company‑sponsored clinical evaluations; collaborated with KOLs to generate real‑world evidence and peer‑reviewed publications supporting product claims.
• Partnered with commercial, R&D and medical affairs teams on labeling, risk management (ISO 14971), market access activities and training to support product adoption in hospitals and wound‑care settings.

Hollister Incorporated is an independent, employee‑owned global manufacturer of healthcare products and services, specializing in ostomy, continence, wound and critical care solutions.

• Managed regulatory submissions and lifecycle activities for medical devices and wound‑care products across multiple geographies.
• Interpreted evolving regulatory requirements and provided regulatory intelligence to product teams to align design and labeling with market expectations.
• Coordinated cross‑functional reviews (design, clinical, labeling, post‑market surveillance) to prepare technical files and support audits and inspections.
• Implemented process improvements for regulatory documentation, adverse event reporting and registration workflows to reduce cycle time and improve compliance.
• Supported internal and external stakeholder engagement, including preparation for regulatory authority interactions and product recalls/field actions as required.

Abbott is a multinational healthcare company delivering diagnostics, medical devices, nutrition and pharmaceutical products aimed at improving patient health worldwide.

• Developed and executed regulatory strategies for diagnostics and/or device product portfolios to support global registrations and market access.
• Prepared regulatory submissions and ensured dossier completeness for interactions with US and international regulatory bodies.
• Collaborated with R&D, clinical and manufacturing teams on submission content, design controls, verification/validation and labeling to meet regulatory expectations.
• Led regulatory risk assessments and supported change control, complaint handling and post‑market surveillance activities.
• Coordinated cross‑functional teams during regulatory inspections and supported remediation activities when needed.

Sanofi Pasteur is the vaccines division of Sanofi, focused on research, development and manufacture of vaccines to prevent infectious diseases worldwide.

• Provided regulatory and technical consulting support related to vaccine development and lifecycle management.
• Advised on regulatory strategy, submission planning and interactions with health authorities for clinical and manufacturing activities.
• Supported GMP/compliance assessments, regulatory documentation and oversight of quality agreements with contract manufacturers.
• Contributed to clinical operations planning and regulatory documentation to support study start‑up and maintenance.
• Delivered targeted training and mentoring to client teams on regulatory requirements and best practices for vaccines.

Vectech Pharmaceutical Consultants is a specialized consulting firm providing hands‑on engineering, contamination control, facility design and regulatory mentoring services to pharmaceutical manufacturers.

• Managed regulatory and compliance projects for pharmaceutical manufacturing clients, focusing on contamination control and facility design.
• Authored and reviewed regulatory and validation documentation (SOPs, qualification protocols, cleaning validations) to support inspections and approvals.
• Led remediation and gap‑closure plans following assessments, and provided onsite training to client personnel on GMP and contamination‑control practices.
• Worked closely with engineering and microbiology teams to develop HVAC, cleanroom and process controls that meet regulatory expectations.
• Provided long‑term mentoring to client teams to build internal capability and reduce reliance on outside remediation support.

Merck (Merck & Co., Inc.) is a global pharmaceutical company focused on research‑driven medicines, vaccines and biologic therapies to address major public health challenges.

• Supported regulatory project management and product lifecycle activities for pharmaceutical or biologic product programs.
• Coordinated CMC and regulatory documentation, change control and submission packaging to support filings and regulatory queries.
• Engaged with cross‑functional teams (CMC, clinical, QA, manufacturing) to drive timely delivery of regulatory deliverables and ensure compliance.
• Maintained regulatory intelligence and supported labeling, post‑approval commitments and pharmacovigilance interfaces as required.
• Contributed to process improvements that streamlined regulatory tracking and submission workflows across programs.