Melina Cioffi
Regulatory Affairs Leader
- Role
- Senior Vice President at Aquestive Therapeutics
- Location
- Morristown, NJ, US
- LinkedIn followers
- 500 followers
About Melina Cioffi
Dedicated, results-driven, detail-oriented Regulatory Affairs professional with 20 years of regulatory experience in the pharmaceutical industry for all phases of product development. Develops and executes global regulatory strategy, serves in various program leadership roles, and has successfully led multiple FDA interactions and submission teams. Knowledgeable in clinical development, clinical pharmacology, nonclinical toxicology, global drug safety, clinical operations, regulatory operations, project management, quality assurance, biostatistics, Experienced with CRO management, development partnerships, and life cycle management activities. Fluent in English and Spanish.
Experience
Senior Vice President
May 2025 — Present · Warren, NJ, US
Education
University of the Sciences in Philadelphia
Doctorate, Pharmacy
2000 — 2006
Skills
- 21 Cfr Part 11
- Ich-Gcp
- Medical Writing
- Regulatory Submissions
- Clinical Data Management
- Clinical Trials
- Ectd
- Glp
- Biotechnology
- Regulatory Affairs
- Lifesciences
- Pharmacovigilance
- U.s. Food and Drug Administration (Fda)
- Gmp
- Oncology
- Toxicology
- Life Sciences
- CRO Management
- Good Clinical Practice (Gcp)
- Therapeutic Areas
- Ctms
- Nda
- Drug Development
- Gcp
- Biopharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
- Clinical Study Design
- Clinical Development
- Neuroscience
- Standard Operating Procedure (Sop)
- CRO
- Regulatory Requirements
- Ind
- Clinical Research
- Clinical Pharmacology
- Capa
- New Drug Application (Nda)
- Validation
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