Regulatory Affairs Therapeutic Area Associate Job in Princeton, New Jersey US
Regulatory Affairs Therapeutic Area Associate
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a long term contract opportunity for a Regulatory Affairs Therapeutic Area Associate for our client in Princeton, NJ. As an RA Therapeutic Area Associate, you will coordinate document submission, review documents, and obtain documents/information for Regulatory submissions from various functional areas. In addition, you will be expected to check for missing information, legibility, translations, etc. Other responsibilities include: Reviewing information from local NNAS contributing departments and providing comments to assure that documents are accurate and complete and comply with FDA regulations Compiling applications and preparing for sign off of INDs/NDAs/BLAs/510Ks Preparing IND amendments and Annual Progress Reports, NDA annual Reports and Annual ADE Reports, IND Safety Reports and Drug 7 Establishment listings Responding to FDA communications Assuring submissions to government agencies in support of investigational and marketed products is complete, in accordance with supervisor requirements and guidance In addition, you will be responsible for interacting with the FDA by performing the following functions: Preparing ROCs for routine FDA contacts Preparing drafts of routine correspondence Assisting in preparation of regulatory documents Assisting with technical preparation for FDA meetings, including review of draft questions and supporting SKILLS In order to be successful within this role, qualified candidates should be proficient in Microsoft Office Suite. EDUCATION/EXPERIENCE Qualified candidates must have a Bachelors degree in Life Science or similar area as well as 3 years of recent Regulatory Affairs experience within the pharmaceutical industry in either a laboratory or clinical research role. If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted. Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.