Angela Dyer brings over 30 years of experience in the biopharma industry and is a seasoned Regulatory Affairs leader. She has held key leadership roles as Department Head of Regulatory Affairs Cangene Corporation, VP & Global Head of Regulatory Affairs Emergent BioSolutions Inc. and Chair of the Canadian Association of Professionals in Regulatory Affairs (CAPRA). In her career, Angela has overseen product licensure and maintenance for 11 approved products across 30+ countries. Her regulatory technical experience spans across various modalities including anti-toxins, small molecules, vaccines, therapeutics, monoclonal/bi-specific antibodies, plasma-derived products, synthetic protein therapies, and combination products.
Her skills include:
Product Development: Develop content maps, gap assessments, content creation and review, label negotiations and managing agency response requests through the license application review process.
Technical Expertise: Define data and source documents required for CTA, IMPD and IND submissions, and compile regulatory dossiers for successful clinical trial start-up. Experienced in multiple, global clinical development programs spanning Phases 1 - 3.
Regulatory strategy: Experienced in BLA, NDA, MAA, NDS, EUNDS, and all post-licensure submission sub-types, including extensive experience in leveraging the PACMP (post-approval change management pathway) with FDA for CMC changes. Experienced in all special and expedited pathways including Fast Track, Breakthrough Therapy, Animal Rule, Accelerated Approval, PRIME, Conditional Approval and Access Consortium.
Compliance: Prepared meeting request, briefing books, slides and scripts for a variety of meeting types, including:
- FDA: Type A, B, C, D (e.g. pre-BLA, pre-IND, INTERACT), Advisory Committee,
- Health Canada: pre-CTA, pre-NDS/EUNDS,
- EMA: Scientific Advice, pre-MAA, Oral Explanation.
Business Strategy: Strategic input into label claim development, considering clinical trial endpoint design to support desired commercial labeling. Building CCDS and labeling operational processes to create and maintain compliant labels.
Project Management: Long-range enterprise strategic planning, enterprise transformation and change management, regulatory functional leadership for RA, RegOps/publishing, information management, labeling, advertising and promotion, change control assessment, site compliance and regulatory intelligence.
Angela has a PhD in Molecular Virology from the University of British Columbia, a Certified Executive Coaching Certificate from Royal Roads University, and has attained ACC level accreditation with the International Coach Federation.
