Associate Director, CMC Regulatory Affairs

Company: MannKind Corp.
Location: Danbury
Posted on: April 14, 2025

Job Description:

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.Position Summary: 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 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.MINIMUM REQUIREMENTS:
• 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.
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Keywords: MannKind Corp., New York , Associate Director, CMC Regulatory Affairs, Executive , Danbury, New York