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Associate Director, CMC Regulatory Affairs in Cambridge, MA

Sarepta Therapeutics

Cambridge, MA 02139
7w ago


Life Sciences


11 - 15 years

Job Description

The Associate Director, CMC Regulatory Affairs reports to VP, the head of Regulatory CMC and is responsible for leading projects and providing support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed products that are based on Gene Therapy core platforms. The Associate Director works closely with subject matter experts and is responsible for assuring the regulatory CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are of high quality and on time. This position provides product strategy and direction to Tech Ops, Quality, commercial and clinical teams internally and agency engagement and alliance partner interactions externally. It requires strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions. As this team grows and expands, this role may report into a Senior Director, of CMC Regulatory Affairs.

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Valid through: 2020-2-19

About Sarepta Therapeutics

Sarepta Therapeutics Inc. (NASDAQ: SRPT) is a medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts, United States. Incorporated in 1980, the company maintains some laboratory capability in Corvallis, Oregon. As of 2014[update], the company does not commercialize any approved drug. As of 2008, Sarepta has 170 issued medical patents, and over 150 patents pending. The company changed its name from AVI BioPharma and stock symbol from AVII in July 2012 to Sarepta Therapeutics and SRPT respectively. At its founding in 1980, the company was named AntiVirals, Inc. After occupying several research laboratory spaces in Corvallis, the company opened a production laboratory in Corvallis, Oregon, in February 2002 and was renamed AVI BioPharma Inc. The company made headlines in 2003 when it announced work on treatments for severe acute respiratory syndrome (SARS) and the West Nile virus. In July 2009, the company announced they would move their headquarters from Portland, Oregon, north to Bothell, Washington, near Seattle. At that time the company led by president and CEO Leslie Hudson had 83 employees and quarterly revenues of $3.2 million. AVI had yet to turn a profit nor developed any commercial products as of July 2009. The company lost $19.7 million in the second quarter of 2009, and then won a $11.5 million contract with the U.S. Department of Defenses Defense Threat Reduction Agency in October 2009. By this time the company had completed its headquarters move to Bothell. In 2012 the company moved a second time, to Cambridge, Massachusetts, retaining their Corvallis laboratory facility. At the time, CEO Chris Garabedian indicated the move was motivated by the need to recruit expertise in rare diseases.
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