Posted in Compliance 30+ days ago.
This job brought to you by America's Job Exchange
Type: Full Time
Location: Summit, New Jersey
REGULATORY SPECIALIST - CMC BIOLOGICS needed for a CONTRACT opportunity with Yoh's client located in SUMMIT, NJ.
* Support Regulatory CMC Biologics group in the preparation of submissions.
* These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
EDUCATION & EXPERIENCE
* At least a Bachelor Degree required. Master's Degree or PhD preferred.
* Must have 5-7 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
* Experience with Biologic CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
* Experience with CMC regulations for biological compounds
* Experience with Gene/Cell/CAR T Cell therapy CMC regulations
* Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
* Practical knowledge of rest of world post approval guidelines
* Have a solution-oriented approach to problem solving
* Expertise in the drug development process and post approval activities
* Ability to work on complex projects and within cross-functional teams
Opportunity is Calling, APPLY NOW
WHAT'S IN IT FOR YOU*
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits
* 401K Retirement Saving Plan
* Life & Disability Insurance
* Direct Deposit & weekly epayroll
* Employee Discount Program's
* Referral Bonus Program's
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.