Regulatory Affairs Associate

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. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. ITLife Sciences Allied Healthcare CRO Certified MBE|GSA - Schedule 66IGSA - Schedule 621I DIRECT # - 732 – 318 -6506 | (W) # 732-549-2030 – Ext – 324 | (F) 732-549-5549 Email id–seema @irionline.com|www.irionline.com LinkedIn:https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™for Health Care Staffing “INC5000’sFASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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:

v Act as liaison to CRO

v Work with CRO to file initial CTAs (clinical trial applications) and amendments

v Tracking of CTA filings and approvals

v Coordinate Query Management

v Attend SMT meetings for relevant clinical studies

v 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:

Additional Information

Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. ITLife Sciences Allied Healthcare CRO Certified MBE|GSA - Schedule 66IGSA - Schedule 621I DIRECT # - 732 – 318 -6506 | (W) # 732-549-2030 – Ext – 324 | (F) 732-549-5549 Email id–seema @irionline.com|www.irionline.com LinkedIn:https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™for Health Care Staffing “INC5000’sFASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)