Regulatory Affairs Manager

Client 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, 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: