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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

Melina Cioffi's Education

University of the Sciences in Philadelphia

Doctorate, Pharmacy

2000 to 2006

Melina Cioffi's Professional Skills Radar Chart

Based on our findings, Melina Cioffi is ...

Sociable
Persuasive
Consistent

What's on Melina Cioffi's mind?

Based on our findings, Melina Cioffi is ...

52% Left Brained
48% Right Brained

Melina Cioffi's Estimated Salary Range

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.

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)


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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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