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Associate Director, CMC Regulatory
Job ID: 2020-2076
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory Aff - Dept
The Associate Director, CMC Regulatory will develop and implement Global Regulatory and Chemistry, Manufacturing and Control (CMC) Regulatory strategies for products, including drug/device combination products, from development through life-cycle management for the US, EU and other markets. The incumbent will be responsible for regulatory leadership, preparation and support of clinical trial and marketing applications, and ensuring compliance to all applicable regulations and standards. There is focus on CMC with specific expertise in the device component of submissions and on drug/device combination product requirements.
- Prepares and manages CMC Regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions.
- Submissions may include MAAs / NDAs - Module 3 and QOS content, supplemental submissions and responses to health authority questions in support of drug product or drug/device combination product development, commercialization, and lifecycle management.
- Submissions may include IND and other clinical trial applications in support of drug product or drug/device combination product development.
- Supported activities may include API development and validation, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing.
- Member of and serves as a CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub teams.
- Leads regulatory strategy for all activities with Regulatory impact for assigned projects, creating and maintaining CMC Regulatory strategy documents
- In concert with Regulatory Operations, ensures completeness and timeliness of CMC submissions, including through creation and maintenance of associated tracking systems.
- Assures that procedures are maintained and followed for archiving of appropriate records and regulatory documentation, including agency contact records, regulatory filing records, etc.
- Maintains expert knowledge in US and international pharmaceutical and combination product regulations and provides proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, ICH).
- Develops or contributes to and maintain SOPs with an emphasis on adhering to drug and device regulations and delivering high quality solutions to our patients.
- Key contact for Radius drug delivery/device partners.
- BS in life sciences, engineering, or equivalent is required.
- 8+ years in the pharmaceutical industry, including drug/device combination product development and commercialization experience is required
- Additional experience in development and lifecycle management of drug-device combination products is preferred.