Associate Director, CMC Regulatory Affairs
MannKind Corporation
Full-time
Remote friendly (Danbury, CT)
Worldwide
$144,000 - $216,000 USD yearly
Other
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Associate Director, CMC Regulatory Affairs
Company Name
MannKind Corporation
Job Description
MannKind Corporation has an opening for a 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.
Pay Range:
$144,000 - $216,000 per hour