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Senior Director, Regulatory Affairs-Bedminster NJ

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My client is a Public Biopharma focused on Rare Disease  in Infectious and Pulmonary Diseases-Bedminster NJ

You will lead the development of regulatory strategy and manage all regulatory submissions and interactions for this Public company.

You will also— provide guidance on both internal and external regulatory activities- NDs, IMPDs, MAAs, NDAs

You will develop long term strategies and execute short term goals for regulatory, clinical and CMC, in alignment with the company’s commercial goals.

 

Job Requirements:

 

Advanced degree preferred.

10+ years regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience.

Must have a proven track record with IND’d/NDA’s (that were successful)

Experience with Rare Disease drugs  is desired

Direct interaction experience with FDA required.

Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.

 

Please send your resume as an attached WORD doc in confidence directly to [email protected]

 

Why Coastal Search Associates?sfsdfsd

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  • Track record of successfully completing strategic senior searches.
  • Expertise in placing executives across diverse industry and product groups and geographic areas.
  • Immediate candidate analysis and market data.
  • A significantly high percentage of firm resources dedicated to the search process.
  • Comprehensive database and long-term relationships with professionals at all levels.
  • Dramatically larger target lists than many of our competitors, from which we identify and attract the top talent

Integrity

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“The most admirable quality of Mike is his depth of understanding of the Pharma/Biotech industry and its trends. Moreover, he is honest and direct and provides constructive feedback to his stakeholders. Many of us who have worked with Mike have developed a trustworthy bond with him which allows for a candid, objective and productive evaluation of the task at hand. Mike is resourceful and well networked to serve his clientele successfully.” Syed Ali- Pharma Manufacturing

“Mike is a detailed oriented recruiter. He has always found personnel for me quickly and identifies the best of the best. I highly recommend him. He remains in contact with all he meets and assists in establishing contacts even when it does not financially benefit him at the time. He follows through on all leads and is diligent in his efforts” Taffy Williams  PhD – Board Chairman  Pharma

“Understands the business and the skills needed for success.” Mike Treble CEO-Biotechnology

“Mike Terretti is an awesome Recruiter. He is dedicated to finding the right candidate for the position. He is detailed oriented and highly skilled. I would highly recommend Mike Terretti to assist with your recruiting needs. “Christina Smith Pharma HR

“Mike is an outstanding professional with whom to work from the candidate’s perspective. He is cognizant that there are a variety of perspectives to any given situation, and his suggested solutions to issues present in such situations are imaginative and insightful. A real pleasure to work with.”David Lilienfeld MD-VP Drug Safety

“Michael is an insightful, persistent recruiter who is willing to ask the tough questions and go the extra mile to achieve results.”Ullrich Schwertschlag, MD, PhD, FACP– Chief Medical Officer 

“Michael consistently seems to provide his clients with value-add candidates. He will address the needs of both parties whenever possible. He has my full recommendation as a C-level HR resource to the Life Science community.” John Zak M.D., M.B.A, Private Equity Firm and Owner