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30 days old

Regulatory Affairs SubmissionSpecialist

Kelly Services
Bridgewater, NJ 08807
**Regulatory Affairs Submission Specialist**


Kelly has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Regulatory Affairs Submission Specialist with our client, a leader in the pharma industry, located in Bridgewater, NJ.


The Regulatory Affairs Submissions Specialist is responsible for the compilation and submittal of electronic/paper submissions to the Health Agencies and maintaining submission information in the appropriate RA systems.


+ Ensure final documents are submission-ready in accordance with agency guidance and trouble any document issues.

+ Promote document authoring standards. Publish maintenance submissions ARs, PADERs, Correspondences, etc. Support Sr. Specialists with larger submissions hyperlinking/bookmarking/formatting Work on eCopy device submissions and other Hardcopy submissions Schedule, publish and archive single product 2253 submissions.

+ Troubleshoot and address validation issues Complete archive requests according to archiving and document retention strategies and updating the RIMS system.

+ Perform regulatory product/registration data entry in RIM system s

+ Create Low-Level Entities in RIM system s Perform basic training for RA systems Viewing tool and basic formatting Troubleshoot and address issues/questions regarding RA systems, processes and data.

+ Compile basic dossiers for file transfer Perform system validation tasks


**Qualifications**


**BS and minimum 2 years experience**


+ Knowledge of submission standards in various formats

+ Knowledge of good documentation practices and requirements for managing regulated records

+ Capable of utilizing IT systems supporting regulatory affairs such as document management, electronic publishing, and submission systems (e.g., SharePoint, Documentum, InSight Publisher)

+ Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)

+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies


**Important information** : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-17 Expires: 2021-10-18

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Regulatory Affairs SubmissionSpecialist

Kelly Services
Bridgewater, NJ 08807

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