Direct Client
Location Lexington, MA
Job Title Regulatory Affairs Manager
Duration 6+ Months
Must have skill-set [Job Description] Job Function and Description:
• Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
• Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, and clinical study design issues and on timing, logistics and operational recommendations for product development.
• Develop regulatory submission strategies in agreement with defined product development objectives.
• Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects.
• Prepare and submit IND and NDA applications, as well as various amendments and supplements.
• Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
• Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Experience Requirements:
• Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.