ABOUT:

100% remote, Regulatory Affairs manager position. The company has been setting the standard for the drug delivery industry for over 20 years, providing innovative drug delivery devices, components and services to their clients. Within those 20 years, this exciting company has established 30 DMFs with USA FDA and has partnered more than 30 successful NDAs and ANDAs. Do you have combination product experience & interested in the Prescription Product Division? Please Apply below.

Responsibilities:

• Manage and maintain the Regulatory strategies for US market activities and Prescription Division plans
• Manage the Drug-device combination products
• Work cross-function amongst R&D, Quality, Sales, Operations and Marketing teams
• Manage preparations and maintenance of regulatory submissions to FDA and other related Health Authorities
• Documentation Management: DMF, customer files, Combination Product documents, medical devices, materials compliance etc.)
• Manage FDA interactions
• Participate in global integration of Regulatory Affairs

Qualifications:

• Post graduate degree in Regulatory Science, Pharmaceutics or Chemistry
• 8+ years Regulatory experience in within the Medical Device, Combination Products, or medicinal products industry
• EU/US Drug-device experience
• Worldwide Regulatory intelligence
• Global Health authority interactions