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Director, Regulatory Affairs CMC Drug/Devices
Job ID: 2021-2205
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory Aff - Dept
The Director, CMC Regulatory Drug/Devices will develop and implement Global Regulatory and Chemistry, Manufacturing and Control (CMC) Regulatory strategies for products, including drug/device combination products, 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.
- Minimum of BS in life sciences, engineering, or equivalent
- 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.
Equal Opportunity Employer Statement:
Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.