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19 days old

VP of Regulatory, Clinical & Quality

Kelly Services
Corvallis, OR 97331
**VP of Regulatory, Clinical & Quality**



Executive leadership of regulatory, clinical and qualify functions. Oversee globally and provide leadership in these 3 areas, including interacting with regulatory, government and health authorities. Also interface with coprorate partners to develop marketing strategies, directing resources to appropriate areas and provide hands on expertise. Travel up to 40%, domestic and international.



Direct, review and provide strategy for regulatory, clinical, quality guidance and related activities ensurance adherance to government contracts and compliance with regulatory and clinical requirements for submissions.



Plan, oversee and support all regulatory submissions including IND, NDA, MAA, CTA (CTx).



Select CRO's and oversee clinical trials from strategic level



Lead the development of regulatory strategy timelines, staffind and budgets globally.



Provide international strategy for regulatory compliance, filings, supply chain operatsions, marketing, sales and external partners



Support sales via communication to stakeholders of regulatory meetings



Review final reports for studies, manufacturing process, investigator brosures, protocols, trial and regulatory documentation



Interact with key medical and scientific leaders in and outside of company



Primary liaison with FDA, EMA, other health authorities



Handle communications of company's position both internally and externally



Evaluate external opportunities for new technologies for regulatory and clinical implications



Manage Regulatory, Quality and Clinical personell



**Qualifications:**



BS, MD, PhD, PharmD preferred



15 years of pharmaceutical industry experience with emphasis on regulatory affairs, filings, interaction with high levels of health authorities in FDA and other agencies



5 years in clinical and quality



Management experience with direct reports in pharmaceutical industry



In depth knowlege of regulatory strategy for all phases from preclinical to phase 3



GCP, ICH, CFR, GxP knowledge



Prefer small company experience












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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-18 Expires: 2019-12-19

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VP of Regulatory, Clinical & Quality

Kelly Services
Corvallis, OR 97331

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