Sharon Bowen
Senior Director, Regulatory Affairs, Merus N.V.
- Role
- Senior Director Regulatory Affairs at Merus at Merus N.V
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Sharon Bowen
REGULATORY EXPERIENCE • Represent Regulatory Affairs on Global Product Teams and provide regulatory strategy• Lead Regulatory Subteams• Writing and review of submission dossiers• Global MAA Planning Support • Preparation of Orphan Drug Applications, Pediatric Plans (US and EU)• Global CTA Submissions• Health Authority and Advisory Board Meetings• Due diligence OTHER RELEVANT EXPERIENCE Drug Development• Experience with both small molecule as well as biologics development programs• Familiar with GxPs and current regulatory guidelines (US, ICH, EU)• Managed external vendors on behalf of sponsors.• Involved in various aspects of hematopoietic and immunology drug discovery/early development ranging from assay development and cloning to IND-supporting pharmacology and pharmacokinetic studies. Other Competencies• Fluent in German, basic knowledge of French
Experience
Senior Director Regulatory Affairs at Merus
Jan 2022 — Present
Education
University of Massachusetts
M.S., Biomedical Sciences
Purdue University
B.S., Cell and Developmental Biology
Skills
- Clinical Trials
- Oncology
- Ema
- Immunology
- Regulatory Guidelines
- Pharmacology
- Regulatory Requirements
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