Lynn Bayless
Vice President Regulatory Affairs, Gene Therapy- Insmed, Inc.
- Role
- Vice President, Regulatory Affairs, Gene Therapy at Insmed Incorporated
- Location
- Marlborough, MA, US
- LinkedIn followers
- 500 followers
About Lynn Bayless
Vice President and Head of Regulatory Affairs with 20+ years’ Global regulatory experience across an array of therapeutic areas including oncology, ophthalmology, neurology, and metabolic diseases. Regulatory expertise in clinical and nonclinical with a strong working knowledge of regulatory CMC. Tenure predominantly in the orphan disease space. Leadership representation across entire depth of company including Executive Leadership Team, Board of Directors meetings, and Research Steering Committee. Successfully developed regulatory strategies for biologics, including gene and cell therapies and combination products. Expertise in Global regulatory submissions including, but not limited to IND/CTAs, NDA/BLA/MAA, Orphan drug applications, RMAT, rare pediatric disease designation requests, and post approval supplements. Successfully led strategic discussions with FDA/EMA/MHRA/Health Canada that resulted in advancement of programs per predefined timelines. Built high-performing regulatory affair departments from the ground-up. Passionate about mentoring and coaching staff to reach their fullest professional potential.
Experience
Vice President, Regulatory Affairs, Gene Therapy
Aug 2024 — Present
I am thrilled to join a company with a patient-centered mission.
Education
Quinnipiac University
BS, Major: Laboratory Animal Technology/ Pre-Vet Minor: Microbiology
1983 — 1987
Massachusetts College of Pharmacy and Health Sciences
MS, Regulatory Affairs and Health Policy
2000 — 2002
Skills
- Nda
- Rare Diseases
- CRO
- Medical Devices
- Clinical Research
- Clinical Development
- Vendor Management
- Research
- Compliance
- Strategy
- Regulatory Affairs
- Cmc
- Biotechnology
- Drug Development
- Gcp
- Biopharmaceuticals
- Technical Writing
- Clinical Trials
- Hipaa
- R&D
- Ectd
- Cross-Functional Team Leadership
- Orphan Drugs
- Ctms
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Requirements
- Ind
- Biologics
- Regulatory Submissions
- Drug Discovery
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