Brittany Goode

• Global Regulatory Intelligence Lead: Built and operationalized processes to collect, consolidate, validate, and distribute regulatory intelligence to cross‑functional teams and governance bodies across regions and therapy areas.
• Strategic impact analyses: Partnered with SMEs to interpret regulatory changes, produce decision-ready impact assessments, and recommend mitigation or opportunity strategies that informed portfolio and development decisions.
• Knowledge management: Designed and launched a centralized intelligence repository and team site, increasing access to actionable intelligence and reducing redundant inquiries by 40%.
• Communication & governance: Synthesized regulatory trends into concise briefs for senior leadership and governance, improving regulatory readiness and accelerating decision cycles.
• Stakeholder engagement: Coordinated external engagement and tracked agency interactions, supporting influence strategies and ensuring consistent organizational positions.
• Training & enablement: Developed and delivered regulatory intelligence training and playbooks for cross‑functional teams, raising team competency and compliance awareness.

Selected achievements:

• Reduced compliance-related timeline delays by 25% through proactive intelligence and early impact mitigation.
• Increased utilization of intelligence outputs by 40% via new publishing cadence, templates, and targeted stakeholder briefings.
• Drove process improvements yielding a 15% reduction in regulatory operations cost across intelligence and tracking activities.
• Authored and coordinated high-impact regulatory comments and position documents used in external advocacy.

• Expertly monitored and analyzed regulatory changes to identify issues that may impact the development and marketing of stakeholders' products.
• Created effective approaches to regulatory policy activities, including generating positions, stakeholder analysis, tracking, internal and external communications. Successfully executed strategies for (5+) priorities including cell and gene therapies, digital health, importation, combination products, and DTC ads.
• Engaged with the FDA and leverages relationships at OND, CDRH, OTAT, and the Office of the Commissioner to gain intelligence and improve the regulatory framework.
• Authored comment letters (14+) on regulatory and reimbursement issues to help shape and influence key policies impacting stakeholders.
• Wrote updates for stakeholders and internal publications. Developed (2) publications: Regulatory Affairs Communique & Regulatory Rundown blog.
• Represented stakeholders at trade associations (BIO, PhRMA, AdvaMed) and agency meetings (FDA, NIH, CMS) to further regulatory policy strategy and gather intelligence.
• Organized meetings, round tables, briefings, fly-ins, receptions, and webinars with FDA, NIH, patient groups, and trade associations to advance advocacy agenda.

• Developed a regulatory intelligence program that kept the company's leadership updated on regulations affecting the development, approval, and maintenance of products.
• Transitioned company submission processes to electronic common technical document (eCTD).

• Managed (5) eCTD submission projects. Published documents for regulatory submissions in accordance with ICH and FDA requirements for electronic submissions.