16 days old

Regulatory Affairs Manager

Kelly Services
Garden Grove, CA 92841
Kelly is working with a large CRO in Orange County looking for an experienced Regulatory Affairs Manager. If you're looking to be a part of helping the current issues spreading across the globe, apply today!

**Position:** Regulatory Affairs Manager

**Type:** Permanent opportunity


+ Follow internal SOPs and perform record keeping

+ Assist with development of SOPs

+ Assist with and coordinate development of clinical trial support documents

+ Collaborate with the research team to facilitate overall protocol operations

+ Manage Regulatory department staff

+ Provide feedback regarding regulatory processes/capabilities for study feasibility

+ Prepare Informed Consent Documents for early phase clinical trials

+ Maintain internal databases of historical clinical trial information

+ Work closely with Quality Assurance department to ensure audit preparedness

+ Prepare regulatory reports

+ Train and mentor staff

+ Ensure Regulatory department operates in accordance with federal regulations and ICH/GCP standards

+ Coordinate all activities to gain Regulatory approval for clinical studies

+ Prepare all documentation for study approval

+ Manage lab certification and licensing for all sites

+ Approve/review IRB billing for clinical trial submissions

+ Coordinate submission of advertising materials for IRB approval

+ Respond to submission-related queries from sponsor and Regulatory Agencies

+ Develop relationships with external partners and agencies

+ Maintain current investigator credentialing

+ Assist in gathering pre-study documentation from investigators and prepare for site selection


+ Bachelor's Degree Required; Certifications are preferred

+ At least 1 year of experience Managing people

+ At least 5 years of experience in Regulatory Affairs - in Pharmaceutical industry

+ Experience in regulatory submissions and knowledge of drug development process

+ Knowledge of federal and local regulations

Apply today for immediate consideration!

**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-11-16 Expires: 2020-12-17

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Regulatory Affairs Manager

Kelly Services
Garden Grove, CA 92841

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