Job Description

Overview

MannKind Corporation has an opening for a Associate Director, CMC Regulatory Affairs in Danbury, CT.

Responsibilities

• 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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