HANNA BURR NYBERG
Park City
Summary
Strategic business and operations leader with 14+ years of experience driving enterprise initiatives across biotechnology organizations supporting biologics, oncology, rare diseases, vaccines, dermatology, neuroscience, and cell & gene therapies. Proven success leading cross-functional programs, implementing AI-enabled operational improvements, managing external partners, improving business processes, and translating complex scientific information into strategic business outcomes. Known for building consensus across executive leadership, R&D, Commercial, Manufacturing, Clinical Development, Regulatory Affairs, Supply Chain, Quality, and Operations teams.
Overview
4
4
Languages
1
1
Certification
14
14
years of professional experience
Work History
Senior Regulatory Affairs & Strategic Operations Manager
Acadia Pharmaceuticals
06.2025 - Current
- Spearhead AI-enabled transformation initiatives that modernize Regulatory Affairs and R&D workflows, improving document quality, operational efficiency, and consistency.
- Evaluate emerging AI technologies and identify opportunities to automate complex business processes while maintaining quality and compliance expectations.
- Lead cross-functional process improvement initiatives, creating scalable SOPs, templates, governance documentation, and standardized operating practices.
- Translate complex manufacturing, analytical, and process development information into strategic documentation supporting IND, BLA, and MAA submissions while partnering closely with scientific SMEs.
- Directed development of Acadia's internal R&D knowledge platform (Acadium), partnering with stakeholders to enhance knowledge sharing, streamline onboarding, and strengthen governance and communication across departments.
- Led enterprise-wide initiatives across R&D, Manufacturing, Process Development, Analytical Development, Regulatory Affairs, Quality, and Operations supporting multiple global development programs, enhancing cross-functional collaboration.
- Serve as a trusted partner across technical and business functions, aligning competing priorities and driving initiatives through completion.
Regulatory Medical Writing Manager (Quality Operations & AI Leadership)
Genmab
02.2024 - 06.2025
- Managed global medical writing quality operations for multiple oncology programs, ensuring compliance and consistency in documentation.
- Led AI implementation initiatives that improved quality review workflows, increased efficiency, and standardized global quality processes.
- Designed AI-assisted review approaches to reduce repetitive manual work while improving consistency.
- Managed external vendors and contractors including onboarding, training, workload allocation, quality oversight, and performance management.
- Developed executive tracking dashboards and operational metrics to enhance visibility into quality activities and portfolio status, facilitating informed decision-making.
- Partnered with global regulatory, clinical development, medical writing, and operations leadership to streamline cross-functional execution, optimizing collaboration and communication.
Regulatory Affairs Specialist
Mirati Therapeutics
10.2022 - 07.2024
- Coordinated complex cross-functional deliverables supporting FDA, EMA, and international regulatory submissions.
- Collaborated with Legal, Commercial, Manufacturing, Clinical Development, Safety, Medical Affairs, Supply Chain, and Regulatory teams to facilitate global product development.
- Enhanced quality systems and governance frameworks to support successful commercialization efforts.
- Managed strategic priorities to ensure alignment and effective communication across diverse stakeholder groups.
Senior Regulatory Medical Writer / Program Lead
Alkermes
06.2018 - 10.2022
- Managed large cross-functional CSR appendix programs requiring coordination across numerous departments and aggressive timelines.
- Created standardized processes, templates, governance documentation, and training programs that improved operational efficiency.
- Directed enterprise-wide initiatives involving Regulatory Operations, Medical Writing, Clinical Operations, Data Management, Biostatistics, Medical Affairs, Supply Chain, and executive leadership.
- Partnered directly with Directors and Vice Presidents while mentoring contractors and new employees.
Regulatory Affairs & Strategic Consultant
Global Regulatory Consulting
08.2012 - 06.2018
- Managed consulting engagements for biotechnology and pharmaceutical companies including Takeda, Sarepta, Genzyme, Ariad, and Synergeva.
- Cultivated trusted client relationships while coordinating international cross-functional teams to streamline product development and commercialization efforts.
- Supported oncology, biologics, and medical device programs through regulatory strategy, technology transfer, and operational improvements.
- Developed standardized business processes and governance documentation, resulting in regulatory strategies that enhanced compliance and operational consistency for client organizations.
Education
Medical Writing & Editing Graduate Certificate -
University of Chicago
Chicago, IL01-2017
Bachelor of Arts - English
Arizona State University
Tempe, AZSkills
- Strategic Initiatives
- AI Transformation
- Digital Transformation
- Cross-Functional Leadership
- Program Management
- Business Operations
- Executive Communication
- Process Improvement
- Organizational Effectiveness
- Change Management
- Vendor Management
- Knowledge Management
- Governance
- Commercialization Support
- Operational Excellence
Languages
- English (Native)
- Swedish (Native)
- French (Fluent)
- German (Conversational)
- Spanish (Conversational)
Board Leadership
Board Member & Co-Founder, Swedish Women's Educational Association (SWEA) of Utah
Ai Digital Transformation
- Led adoption of AI-enabled workflow improvements across Regulatory Affairs and Medical Writing organizations.
- Developed AI-assisted quality review processes that improved operational efficiency and consistency.
- Evaluated emerging AI technologies for enterprise business applications.
- Helped establish scalable processes and governance supporting responsible AI adoption.
Languages
English
Native/ Bilingual
Swedish
Native/ Bilingual
French
Professional
Spanish
Limited
Accomplishments
- Nyberg E, Burr Nyberg H. “RECOREs: African Regional Centres of Regulatory Excellence.” Regulatory Focus. December 2014. Regulatory Affairs Professionals Society.
- Nyberg E, Rupert, A, Burr Nyberg, H. “Northern Africa: Status of Regulatory Strategies for the Region.” Regulatory Focus. December 2014. Regulatory Affairs Professionals Society.
- Nyberg E, Burr Nyberg, H. "South Africa Medicines Regulatory System Overview.” Regulatory Focus. January 2015. Regulatory Affairs Professionals Society.
Certification
- The Honor Society of Phi Kappa Phi
- Regulatory Affairs Professional Society (RAPS)
- American Medical Writers Association (AMWA)
- Quality Professionals Society
- Drug Information Association (DIA)
Timeline
Senior Regulatory Affairs & Strategic Operations Manager
Acadia Pharmaceuticals
06.2025 - Current
Regulatory Medical Writing Manager (Quality Operations & AI Leadership)
Genmab
02.2024 - 06.2025
Regulatory Affairs Specialist
Mirati Therapeutics
10.2022 - 07.2024
Senior Regulatory Medical Writer / Program Lead
Alkermes
06.2018 - 10.2022
Regulatory Affairs & Strategic Consultant
Global Regulatory Consulting
08.2012 - 06.2018
Medical Writing & Editing Graduate Certificate -
University of Chicago
Bachelor of Arts - English
Arizona State University