Regulatory affairs Manager

Regulatory Affairs Manager

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Location Lexington, MA

Job Title Regulatory Affairs Manager

Duration 6+ Months

Must have skill-set 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.

Qualifications:

Regulatory and product development background.