Regulatory Affairs Associate

Regulatory Affairs Associate

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.

Job Description

Job Title: Sr. Associate II Regulatory Affairs Location: Cambridge, MA Duration: 6+ months (possibility of extension) JOB ROLES & RESPONSIBILITIES Regulatory Submissions (CTA) Associate (Sr. Associate II level)

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Qualifications

Job Title: Sr. Associate II Regulatory Affairs Location: Cambridge, MA Duration: 6+ months (possibility of extension) JOB ROLES & RESPONSIBILITIES Regulatory Submissions (CTA) Associate (Sr. Associate II level)

· Responsible for submission activity on several programs

· Report to head of submissions group, work with Regulatory Development managers on each program

· Responsibilities include:

• Act as liaison to CRO
• Work with CRO to file initial CTAs (clinical trial applications) and amendments
• Tracking of CTA filings and approvals
• Coordinate Query Management
• Attend SMT meetings for relevant clinical studies
• Liaise with CMC regulatory on CMC CTA filings/amendments

QUALIFICATIONS:

· Ideally 1-2 years' experience in Regulatory Affairs.

· An understanding of Clinical Operations and drug development is required.

· Experience in preparing Regulatory submissions preferred.

· Experience in Clinical Operations or related area will also be considered.

EDUCATION: