Key Words
Keywords can include skills or job number
State
View All jobs
 
 
»Back     »Send to a Friend    »Apply
Title : NVA- Regulatory CMC Associate Manager -470
State : New Jersey   Date : Jan 8, 2019
Experience Level :  
Position Type : Regulatory CMC Associate Manager      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: East Hanover, NJ


Job Title: Regulatory CMC Associate Manager


Duration:  11+ months (extendable) contract on W2



Duties:



Independently manage or assist and support regulatory CMC managers in the following activities: Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance. Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.Single point of contact with other line functionsReview CMC regulatory documentation to ensure strategic direction and regulatory compliance are met. Collecting documentation from other line functions to support submission preparation Ensure databases are maintained to compliance.



Skills:



 2-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. Effective planning, organizational and interpersonal skills. Reasonable approach to risk assessment. Excellent written/spoken communication and negotiation skills. Computer literacy.


Education:


Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.


---

Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
Visit our job boards for a listing of open positions.
For IT Positions go to www.newagesys.com/career.html 
For Clinical Positions go to www.newageclinical.com/careers.html 
Inc 5000 Company for 8th Time!

For IT jobs with NewAgeSys, please click on the following link:
NewAgeSys