NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

CMC Regulatory Manager

Company: US Tech Solutions
Location: New Brunswick
Posted on: June 20, 2020

Job Description:

Job Title:--CMC Regulatory Manager Location:--New Brunswick, New Jersey Duration: 12 months Client : Pharmaceutical CompanyJob Description:Represent regulatory CMC--on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for marketing applications--and/or clinical trial applications for small molecule projectsReview and provide regulatory assessments on change controls (commercial and/or development products)Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documentsManage collaborative relationships with diverse teamsUtilize electronic systems for dossier creation and tracking regulatory informationEducation, Experience, Skills:Minimum of Bachelor's Degree, scientific discipline, with minimum of 4-6+ years of related experienceCMC regulatory experience, including post-approval experience desiredKnowledge of CMC regulatory requirements during development and post-approvalKnowledge of pharmaceutical development, including drug substance and drug product and analytical methods.Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently--Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timelinessAbility to interpret global regulations and guidanceStrong oral and written skillsProficient with electronic systemsOccasional Travel Required

Keywords: US Tech Solutions, New Brunswick , CMC Regulatory Manager, Executive , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Fourteen Foods: Dairy queen shift manager
Description: Job Description At DQ, we require a unique set of skills, like crafting the perfect cone curl. We teach soft skills as we dish out soft serve. You'll never get tired because there are so many ways to (more...)
Company: Fourteen Foods
Location: Hempstead
Posted on: 07/3/2020

Front End Technology Engineer / Product Manager - Quantitative Investing
Description: Love your job br br REQUIREMENTS br ul br li Expertise in React or Node li Strong with JavaScript li Must have been a top student in your programs at school and have significant software (more...)
Company: Job Juncture
Location: Hempstead
Posted on: 07/3/2020

Hospice Medical Director
Description: Hospice/Palliative Medicine opening in Reading, Pennsylvania. This and other physician jobs brought to you by DocCafe.com The Section of Hospice and Palliative Medicine at Reading Hospital is seeking (more...)
Company: Tower Health
Location: Reading
Posted on: 07/3/2020


11B Infantryman - Management Training
Description: The Infantry is the backbone of the Army. These Soldiers fill the literal boots on the ground who are responsible for taking or holding ground during any combat operation. You'll attack, repel, and capture (more...)
Company: Army National Guard
Location: Reading
Posted on: 07/3/2020

Bookkeeper For Property Management Company
Description: Bookkeeper with Property Management Experience br br We are looking for a focused individual to be responsible for the income and expenses of a large portfolio of commercial and residential properties. (more...)
Company: Century 21 Advantage Gold
Location: Camden
Posted on: 07/3/2020

Assistant Clinical Nurse Manager
Description: Clinical Nurse Manager opening in Scranton, Pennsylvania. This and other nursing administrator jobs brought
Company: KA Recruiting Inc.
Location: Scranton
Posted on: 07/3/2020

Finance Director
Description: Praxair, Inc. is a leading industrial gas company in North and South America and one of the largest worldwide . Praxair produces, sells and distributes atmospheric, process and specialty gases , and high-performance (more...)
Company: Jobs Interviewing Now from HCS
Location: Danbury
Posted on: 07/3/2020

Fund Accounting & Administration Managing Director (f/k/a AIS Fund Adm
Description: Fund Accounting Administration Managing Director f/k/a AIS Fund Administration Manager State Street Bank and Trust Company Clifton, New Jersey : position within the Hybrid Fund Services Team in (more...)
Company: State Street.
Location: Clifton
Posted on: 07/3/2020

Right of Way Manager
Description: RK K is seeking a specialist in large scale utilities real estate and right of way ROW projects. You will be responsible for tasks such as scope preparation, budget preparation and maintenance, negotiations, (more...)
Company: Rummel Klepper and Kahl,
Location: Wilmington
Posted on: 07/3/2020

Senior Manager Procurement Business Operations
Description: SunIRef:it Imagine...working for a company that knows that its people are the key to its success in the marketplace. A company in which achieving extraordinary results and having a stimulating work experience (more...)
Company: Campbell Soup Company
Location: Camden
Posted on: 07/3/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds