Regulatory Affairs Manager

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: 

• 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.

Contact:

VAIBHAV SINGH

Technical Recruiter 

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

(D) 732-429-1647 (Tel) 732-549-2030 Ext. 225 (F) 732-549-5549

vaibhav @irionline.com | www.irionline.com (Ignore Spaces)

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year