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.

Regulatory and product development background.

Thanks,

Sri

Technical Recruiter

INTEGRATED RESOURCES, INC.

4 Ethel Road, Suite 403B Edison, NJ 08817

IT REHAB CLINICAL NURSING Inc. 5000 – 2007- 2013 (7th Year)

Direct: (732) 549 2660

Tel: (732) 549-2030 x 127

Fax: (732) 549-5549

http://www.irionline.com