The Associate Director, CMC Regulatory - Devices will develop and implement Global Regulatory and Chemistry, Manufacturing and Control (CMC) Regulatory strategies for products, including drug/device combination products and companion diagnostics, from development through marketing approval for the US, EU and other markets. The incumbent will be responsible for regulatory leadership, preparation and support of US BLA and NDA regulatory submissions, and ensuring compliance to all applicable regulations and standards, with focus on CMC and 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 BLAs, 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 or commercialization.
- Supported activities may include companion diagnostic development, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing.
• Is a member of and serves as a CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub-teams
• Is the subject matter expert for the new EU Medical Device Regulations
• 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), with a particular focus on device regulations.
• 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.
• Minimum of BS in life sciences, engineering, or equivalent required.
• RAC certification and/or other regulatory certification is a plus.
• 8+ years in the pharmaceutical industry, including drug/device combination product development and commercialization experience.
• Experience with regulatory requirements and submissions for companion diagnostics and medical devices.
• Experience in developing and submitting successful BLA/NDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines, with demonstrated expertise in drug/device combination products.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.