Kristen Manion
Vice President of Chemistry, Manufacturing, and Controls (CMC) and Quality at Paratek Pharmaceuticals
- Role
- Vice President Regulatory Affairs Quality and Manufacturing at Paratek Pharmaceuticals
- Location
- Wayne, PA, US
- LinkedIn followers
- 500 followers
About Kristen Manion
Strategic global Regulatory Affairs and Quality leader with emphasis in Chemistry, Manufacturing, and Controls (CMC) and 20 years experience in the pharmaceutical industry. Key areas of expertise include: interacting and negotiating with FDA and other Health Authorities to achieve favorable resolutions; creation and execution of innovative Regulatory strategies for development and marketed products leading to timely submission and product approval; in-depth knowledge and expertise of drug development, early phase drug registration, product approvals, life cycle registration activities, and maintenance of dossiers, creation, execution, and maintenance of quality management system and lead health authority inspections.
Experience
Vice President Regulatory Affairs Quality and Manufacturing
Jan 2023 — Present · US
Skills
- Cmc
- Clinical Development
- Standard Operating Procedure (Sop)
- Gxp
- Drug Development
- Biopharmaceuticals
- Regulatory Requirements
- Ind
- U.s. Food and Drug Administration (Fda)
- Validation
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Fda
- Capa
- Pharmaceutics
- Quality Assurance
- Change Control
- Clinical Trials
- Regulatory Affairs
- Cross-Functional Team Leadership
- Technology Transfer
- Pharmacovigilance
- Gmp
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