Joan Schmidt
Director, Regulatory Integration and Alliance Management at Bristol-Myers Squibb Company
- Role
- Director, Regulatory Integration and Alliance Management at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Joan Schmidt
A Regulatory Affairs professional with 35 years’ experience in the pharmaceutical industry. Successfully planned and managed submissions for new global investigational and marketing applications over multiple therapeutic areas, with 17 years’ focus on biologics. Experienced at leading global drug application filing teams and supervising staff with the appropriate speed and versatility to achieve project goals and provide quality global regulatory submissions for key company growth drivers. Possess a comprehensive knowledge of filing regulations and regulatory guidelines and a high proficiency in general computer skills. Responsible for managing a staff of skilled regulatory professionals. Provided oversight and influence of procedural documents and development of new business processes for optimization of submission management.
Experience
Director, Regulatory Integration and Alliance Management
Dec 2022 — Present · Princeton, NJ, US
Education
Rutgers University
BA, Chemistry
1984 — 1988
Skills
- Validation
- Infectious Diseases
- Strategic Planning
- Pharmaceutical Sales
- Biotechnology
- Medical Affairs
- Ich-Gcp
- Clinical Research
- Cardiology
- Capa
- Clinical Monitoring
- Pharmacovigilance
- Edc
- Gmp
- Therapeutic Areas
- Ctms
- Cross-Functional Team Leadership
- Change Control
- 21 Cfr Part 11
- Process Improvement
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Submissions
- Immunology
- Clinical Data Management
- Diabetes
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Requirements
- Ind
- Regulatory Affairs
- Lifesciences
- CRO
- Clinical Trials
- Pharmaceutics
- Drug Discovery
- Medical Writing
- Ectd
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