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Title : SG- Regulatory Affairs Specialist III -050
State : New Jersey   Date : Oct 22, 2020
Experience Level :  
Position Type : Regulatory Affairs Specialist III      
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: Bridgewater, NJ

Job Title: Regulatory Affairs Specialist III

Duration: 6+ months (extendable) contract on W2


|| Title: CMC Small Molecule Marketed Contractor as Individual Contributor || 

Duties: 

The candidate is responsible for assisting in the post-approval maintenance of products within the portfolio of Regulatory CMC Small Molecule Marketed function. Primary responsibilities will be the following: 
Marketed product support for global maintenance (US, EU and ROW) activities 
a. Assessment of change controls from Industrial Affairs and dossier requirements 
b. Ensure dossier publishing with Reg Ops with any necessary coordination with GRA Leads 
c. Creation of any response documents and coordination with all partners for completion 
d. Appropriate database management (VEEVA RT, etc.) 
e. Renewal activities according to current SOPs and Global Planning for all markets 
Variation Tracking with Affiliates 
Other support activities including administrative documents for all submission types 
eCTD Application Forms (MRP,CP, etc.) Other activities such as below may be assigned based on the level and ability of the incumbent. 
Regional/Pharmaceutical Operations/Industrial Affairs sponsored non-R&D life-cycle management projects 
Territory extensions / new registrations 
Support of initiatives within Reg CMC

Skills: 

Global operational experience with a mid/large-size Regulatory CMC and Devices Organization. Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues. Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences. Fluency (oral and written) in English language is strongly recommended. Potential to be able to mentor and train other contractors is desirable but not essential. Be proficient in the use of databases and tools (Regulatory databases, Excel, PowerPoint, etc.).


Qualifications: 

Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable. An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) or direct Regulatory CMC experience is required. 



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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