MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT. Lead and compile global regulatory submissions using eCTD. Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input and guidance on interpretation of deficiency comments and guide the formulation of responses. Assist with development of documents submitted to health authorities and related to expedited regulatory programs, meeting requests, meeting background packages, and other regulatory documents of this nature. Author internal regulatory documents, such as Regulatory Assessments and Strategy documents. Review internal change controls and assess impact to regulatory filings.
Salary of 150,904 to $210,000 per year.
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 or email resumes to careers@mannkindcorp.com or mail to MannKind Corporation, Attn. HR, 30930 Russell Ranch Road, Ste. 300, Westlake Village, CA 91362.
#J-18808-Ljbffr...If you're a natural problem-solver who loves helping people and you're fluent in both French and English, we want you on our team. Join TalentPop as a French+English Bilingual Customer Support Specialist and be the friendly, reliable support our clients and customers...
...Company Overview Complete Design, Inc. is a full-service architectural, engineering, and land surveying firm based in Wenatchee, Washington. For over 25 years, weve delivered innovative, high-quality solutions for residential, commercial, municipal, and land development...
...Job Description Job Description Now Hiring: Production Manager Job Description We are seeking a detail-oriented and hands-on Production Planner & Shop Manager to oversee and coordinate all aspects of production planning and daily shop floor operations. This dual...
...Ready Mix Truck Driver/Operator Hooker Creek Companies LLC is proud to be a Central Oregon locally owned full service construction materials provider. We are an award winning company providing sand & gravel, ready-mix concrete, rental equipment and supplies, new and...
...their biggest challengesin entertainment, technology, lifestyle, sports, and gaming. Together, we create with confidence.Were proud... ...for an Analyst or Senior Analyst to join our entertainment research teampartnering with the worlds top studios and streaming platforms...