Regulatory affairs Manager

 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.