Regulatory eSubmissions Associates

Multiple Positions in Marlborough, MA; San Diego, CA; Philadelpia, PA and Slough, UK

The Regulatory Affairs Associate will be an integral part of the electronic submission publishing team. Under the direction of Manager, Regulatory Affairs Associate will assist with the day to day tasks related to the preparation of electronic regulatory submissions. Participate in Regulatory Operations meetings and training initiatives, project team meetings, and maintain relationships with clients and other departments within the organization. Assist as needed in the development and implementation of regulatory documentation standards and procedures related to electronic publishing. Assist in coordinating, tracking, assembling, timely distribution, and archiving all relevant regulatory guidance documents in accordance with organizational procedures. Maintain knowledge of regional regulatory requirements related to electronic regulatory submissions to FDA, EMEA, JPMA, and HC. Provide client support for electronic/standard submissions related issues.

Must possess:

Strong interpersonal and written/verbal communication skills; Excellent organizational, planning, and follow-up skills. Must be detail-oriented, flexible, self-starting, and able to meet tight deadlines. Excellent computer skills; MS Word is required. Experience with Adobe Acrobat, document scanning, and electronic document management is a plus.

Requirements:

Bachelor's degree and 0 to 3 years experience in the life science industry.
Regulatory Affairs experience a plus,
RAC desired and/or highly encouraged

Please send a resume in Word or PDF format to: HR@datafarminc.com