Yoh Services LLC Project Manager in Woodcliff Lake, New Jersey

REGULATORY AFFAIRS PROJECT MANAGER needed for a contract opportunity with Yoh Scientific's client located in NORTHERN NEW JERSEY.
This position will be approximately 30 hours per week with flexibility in terms of specific days/hours, and 1 day per week can be working remotely if desired.
* Lead multiple IND and NDA-related regulatory affairs projects concurrently and ensure timelines are followed
* Conduct/hold meetings with various departments/groups/teams internally and also with external stakeholders as needed
* Monitor and track all applications and submissions that are under regulatory review and communicate progress internally
* Ensure responses/follow-ups to health authorities are submitted by the appropriate deadlines, while also meeting all applicable regulations
* Minimum of a BS is required, ideally in a scientific/healthcare field. Advanced degree and/or PMP certification would be preferred
* At least 4-5+ years of pharma/biotech industry experience is required with 2+ years being in a regulatory affairs / project management role
* Solid project management and organizational skills are needed; MS Project experience is required
* Strong understanding of local and global regulatory affairs & strategy activities, documents, timelines, and regulations, i.e. GCP, ICH, GMP, etc.
* Previous experience working in submissions and a solid understanding of the various types of submissions/registrations
* Ability to effectively communicate and work cross-functionally, lead large, global projects across multiple time zones and ensure project milestones are consistently managed
Opportunity is Calling, Apply Now!
Recruiter: Logan Kinney
We welcome you to be a part of one of the largest 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 Programs
* Referral Bonus Programs
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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.

Employer's Job# 210296
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