Sr. Regulatory Associate at Plainsboro

Job Description

Sr. Regulatory Associate Opportunity in Plainsboro, NJ

 

Kelly Scientific Resources

 

Make the most of your valued expertise!

 

Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Sr. Regulatory Associate in Plainsboro, NJ.

 

Responsibilities and prospects for Sr. Regulatory Associate include:

• Advise stakeholders of submission completion
• Find information and potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward
• Assist in the preparation of regulatory documents
• Compile applications and prepare for sign-off INDs/NDAs/BLAs/510Ks, IND amendments and Annual Progress Reports, NDA annual Reports and Annual ADE Reports, IND Safety Reports, Drug Establishment Listings, responses to FDA communications, among others as assigned, assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisors requirements and guidance
• Assist Manager/Director in review of labelling for marketed products and new products as assigned
• Coordinate document submission in accordance with supervisors requirements and guidance
• Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions
• Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable
• Use of template correspondence as appropriate, ensuring that all new information is correct
• Prepare and review ROCs for routine FDA contacts
• Prepare and review drafts of routine correspondence

Education and experience for Sr. Regulatory Associate include:

• Bachelors Degree required; Life Science preferred
• Minimum of 3 years regulatory experience

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay
• Access to a comprehensive employee benefits package including health, prescription, vision, dental, and life and short-term disability insurance
• Paid service bonus and holidays
• Portable 401(k) plans
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center

About Kelly Services®

Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.

Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.

Want more information? Visit kellyservices.com/science

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Job Requirements

 
Country: USA, State: New Jersey, City: Plainsboro, Company: Kelly Scientific Resources.