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Regulatory Associate - CMC

Makro Scientific

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Job Snapshot
Location:
West Point, PA 19486 (map it!Map it! )
Employee Type:
Contractor
Industry:
Pharmaceutical
Biotechnology
Manages Others:
No
Job Type:
Health Care
Pharmaceutical
Education:
2 Year Degree
Experience:
2 to 5 years
Post Date:
11/6/2009
Contact Information
Contact:
Ramesh
Phone:
973 481 0100 ext: 3059
Ref ID:
16806-RA
Description

Dear Candidate,

 

 

We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known life sciences organizations throughout the United States. Our broad geographic reach, scalability and immense talent pool enable us to reliably meet the needs of our esteemed clients.

We thoroughly understand and believe that long lasting in-depth relationships with clients is an integral part in the business environment and equally important is the relationship with our candidates.

 

Our vision is to become a most reliable 'connector' between Pharmaceutical, Biotechnology, Medical Device companies and Best Talent.

 

 

Job position: Regulatory Associate - CMC

Location: West Point, PA

Duration: 6 Months

Position type: Contract

 

Duties:

 

  • Prepares CMC information for worldwide marketing of pharmaceutical products (NDA, WMA, CTD) to include annual reports, registration renewals, supplements / variations, INDs/CSAs, and responses.
  • Interfaces with Registration Managers on post-approval changes, performs tracking and follow-up and performs routine assignments to support a product / product franchise.
  • Adheres to requirements for use of new and existing CMC systems (PCR, ACR, CoreWMA, PMD, ORION, WMCS).
Requirements

Skills:

  • Bachelor Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline preferred
  • Prior industry experience, particularly within the CMC field

 

Searching for more jobs? Visit at:

http://makroscientific.com/makroscientific/Jobs/searchJobs.aspx

 

For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005 or email your resume at [Click Here to Email Your Resumé]. We shall be happy to help you.





** Makro is 3-time INC 5000 Company for 2007/2008/2009

** Makro is 3-time FAST 50 in NJ for 2005/2006/2007 (by Deloitte)

** Makro is 3-time FAST 500 in USA for 2005/2006/2007 (by Deloitte)

** Makro is NJ Finest for 2008 (by NJBIZ)

 

We are an equal opportunity employer and your application will be considered without discrimination due to race, religion, gender, age, national origin, disability, veteran status or sexual orientation
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