MannKind Corporation has an opening for an Associate Director, CMC Regulatory Affairs in Danbury, CT. DUTIES: Lead and compile global regulatory submissions using eCTD. Oversee preparation of responses to deficiency comments/letters from health authorities and provide input. Assist with development of documents submitted to health authorities and expedited regulatory programs, meeting requests, meeting background packages, and other regulatory documents. Author internal regulatory documents. Review internal change controls and assess impact to regulatory filings. Requires: Pharm.D or Ph.D. Degree in Regulatory Affairs, Life Sciences, or a related field, or the foreign equivalent. 5 years of experience in offered position or related role. At least 5 years of experience working with analysis and interpretation of complex problems and data in regulatory affairs domain. At least 5 years of experience working with global (U.S., LATAM, EMEA, and APAC) regulatory guidelines and other regulations/requirements. At least 5 years of experience working with small molecule/biologics. Apply at https://mannkindcorp.com/careers/ or email resumes to careers@mannkindcorp.com or mail to MannKind Corp., Attn HR 30930 Russell Ranch Road, Ste 300, Westlake Village, CA 91362.
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