Melina Cioffi
Director, Regulatory Affairs
Regulatory Affairs Leader
Morristown, New Jersey, United States
Section title
Melina Cioffi's Email Addresses & Phone Numbers
Melina Cioffi's Work Experience
Forest Laboratories (now Allergan)
Director, Regulatory Affairs
October 2014 to December 2018
Dainippon Sumitomo Pharma
Regulatory Affairs Senior Manager
May 2008 to May 2010
Novartis
Post-Doctoral Fellow (Manager-level role)
July 2006 to May 2008
East Hanover, NJ
FDA
Externship
November 2005 to January 2006
Rockville, MD
McNeil Consumer & Specialty Pharmaceuticals
Intern
May 2003 to December 2004
Forest Laboratories (now Allergan)
Associate Director Regulatory Affairs
January 2012 to September 2014
Forest Laboratories (now Allergan)
Assistant Director, Regulatory Affairs
May 2010 to December 2011
Aquestive Therapeutics
Head of Regulatory Affairs
Warren, New Jersey, United States
Axsome Therapeutics, Inc.
Head Of Regulatory Affairs
March 2020 to August 2020
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About Melina Cioffi's Current Company
Forest Laboratories (now Allergan)Deliver and execute global regulatory strategy to cross-functional team for thedevelopment of an atypical antipsychotic compound in multiple CNSindications. Deliver and execute global regulatory strategy to cross-functional team for thedevelopment of an atypical antipsychotic compound in multiple CNSindications.
Frequently Asked Questions about Melina Cioffi
What company does Melina Cioffi work for?
Melina Cioffi works for Forest Laboratories (now Allergan)
What is Melina Cioffi's role at Forest Laboratories (now Allergan)?
Melina Cioffi is Director, Regulatory Affairs
What is Melina Cioffi's personal email address?
Melina Cioffi's personal email address is m****[email protected]
What is Melina Cioffi's business email address?
Melina Cioffi's business email addresses are not available
What is Melina Cioffi's Phone Number?
Melina Cioffi's phone (201) ***-*258
What industry does Melina Cioffi work in?
Melina Cioffi works in the Pharmaceuticals industry.
Who are Melina Cioffi's colleagues?
Melina Cioffi's colleagues are Salina Colthurst, Peter Selfridge, Tom McElrath, xiang chen, Philip Miner, Judith Maldonado, Alan M.D., Ray Dwomo, Gilliss Kasey, and Christie Woods
About Melina Cioffi
📖 Summary
Director, Regulatory Affairs @ Forest Laboratories (now Allergan) Deliver and execute global regulatory strategy to cross-functional team for thedevelopment of an atypical antipsychotic compound in multiple CNSindications. From October 2014 to December 2018 (4 years 3 months) Regulatory Affairs Senior Manager @ Dainippon Sumitomo Pharma Regulatory lead for clinical components and operational activities of NDA for schizophrenia; active participation in all NDA module development. Led IND submission for bipolar depression phase 2/3 development program and global clinical trial start up activities. Regulatory lead for phase 2 compound in urology (overactive bladder). From May 2008 to May 2010 (2 years 1 month) Post-Doctoral Fellow (Manager-level role) @ Novartis Drug Regulatory Affairs, NeuroscienceLeadership experience and exposure opportunities with CNS compounds in development and marketed CNS products. From July 2006 to May 2008 (1 year 11 months) East Hanover, NJExternship @ FDA Pharmacy Rotation in the Office of Director.Introduced to the internal hierarchy and processes within FDA.Exposure to SPL initiative (at that time), UNIICODE mapping, and USP pharmacoepia. From November 2005 to January 2006 (3 months) Rockville, MDIntern @ McNeil Consumer & Specialty Pharmaceuticals Drug Regulatory Affairs InternshipHands-on experience with promotional review for marketed compounds: muscle relaxant, ADHD medication; promotional review for OTC products. Led updates to OTC Drug Facts. Exposure to sNDA for OTC NDA product. From May 2003 to December 2004 (1 year 8 months) Associate Director Regulatory Affairs @ Forest Laboratories (now Allergan) From January 2012 to September 2014 (2 years 9 months) Assistant Director, Regulatory Affairs @ Forest Laboratories (now Allergan) From May 2010 to December 2011 (1 year 8 months) Head of Regulatory Affairs @ Aquestive Therapeutics Warren, New Jersey, United StatesHead Of Regulatory Affairs @ Axsome Therapeutics, Inc. From March 2020 to August 2020 (6 months)
Melina Cioffi’s Personal Email Address, Business Email, and Phone Number
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In a nutshell
Melina Cioffi's Personality Type
Extraversion (E), Sensing (S), Feeling (F), Judging (J)
Average Tenure
1 year(s), 10 month(s)
Melina Cioffi's Willingness to Change Jobs
Unlikely
Likely
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There's 73% chance that Melina Cioffi is seeking for new opportunities
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