Kelly Services International Regulatory Submission Expert in Durham, North Carolina

Regulatory Submission Expert Durham, NC

Kelly Scientific Resources is currently seeking a Regulatory Submissions Expert with specific experience in CRO’s and international agencies.

This is a contract (possible contract to hire) role in Durham, NC. Pay is commensurate with experience. Monday-Friday. 1st shift. Potential work from home may be possible as well.

Regulatory Affairs (Global Submissions Expert)

This CRO services clients throughout the world. Right candidate will bring experience with global regulations and global submissions.

This position will focus on Regulatory Submissions – Content, Timeline, Accuracy, and Compliance.

Seek candidate with deep understanding of global Regulatory requirements.

Position will focus on clinical activities. A candidate who is experienced with both clinical and post marketing is a plus.

Company relies heavily on industry databases to manage clinical documents. Right candidate will bring expertise in EV Web, Web Trader, etc.

Right candidate will have a bachelor’s degree (advanced degree preferred) and 3 to 5 years of global regulatory submission experience at a CRO or pharmaceutical company.

Extensive knowledge of FDA, EMEA and ROW Regulatory requirements and practices, with particular focus on Regulatory Submissions

Pre- and post-market experience

Expertise in EV Web, Axway, Web Trader and other similar databases

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm