PaintSquare.com
Follow us on Twitter Follow us on LinkedIn Like us on Facebook Follow us on Instagram Visit the TPC Store
Search the site

 


Director MT CMC Regulatory Support

View All Jobs | Search Jobs | Post a Job

Company: ImClone Systems
Location: NJ - Bridgewater NJ
Posted: 10/16/2012
Salary: N/A

General Summary :

The individual will lead a team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of investigational drug applications (INDs, CTAs) and initial marketing applications, along with required supplements and amendments. Additional responsibilities include assisting the RA (CMC) group with the compilation of responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. This individual will represent this function on multi-disciplinary project teams. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and keep to the timelines established for the respective filings.


Primary Responsibilities:

  • Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses.
  • Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to implement regulatory filings.
  • Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization.
  • Summarize technical reports and information in accordance with developed CMC document templates.
  • Prepare and maintain an up-to-date project plan for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization.
  • Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met.
  • Develop and supervise a multi-disciplinary team.
  • Optimize the document work flow process.
  • Assist manager with the development and maintenance of department budget.

This job was originally posted on CareerBuilder.com. Original job posting

Apply for this job (via CareerBuilder.com)
E-mail this job listing to a friend

Blastox/The TDJ Group, Inc.
Blastox® - One Step Lead Abatement

Sandblast additive delivered to jobsite pre-blended to eliminate hazardous abrasive wastes. Why mix, meter or apply at the job-site? Blast with ease and
Let your painters paint!
1(800)-252-7869


DeFelsko Corporation
PosiTector SST Soluble Salt Tester

Measures the concentration of soluble salts on metal surfaces. Use with all Bresle patch types including the reusable, adhesive-free PosiPatch.


Strategic Materials Inc.
http://www.truabrasives.com/

TruAbrasives™, a clean crushed glass abrasive superior to other abrasives. Save up to an extra 20% on your next order.


BASF
New resins from BASF will have metals loving water!

Excellent corrosion resistance, low VOC, high gloss, thin films www.basf.us/industrialcoatings dpsolutions@basf.com 800-231-7868


Fischer Technology Inc.
DUALSCOPE®FMP100 with DataCenter IP

Transfer customized inspection plans from PC to FMP100 using step-by-step guidance with prompts and pictures throughout the measurement procedure


Tarps manufacturing, Inc.
QUALITY MADE IN AMERICA —Available near you!

CLICK to get a behind-the-scenes look at how Tarps Manufacturing makes the highest-quality tarps right here in the USA — available nationwide.


Termarust Technologies
Termarust (HR CSA) Chemically Stops
Active Corrosion

Arch truss treated with Termarust's (HR CSA) in 2003. This steel arch bridge is rust free on all surfaces including the crevice corroded joints and connections.


Jotun Paints Inc.
Jotun Jotachar 1709

Mesh-free passive fire protection epoxy designed to protect against hydrocarbon pool fire scenarios for up to four hours as defined in the ANSI/UL1709 standard.


Absolute Equipment/Grand Rental Station
TIER 4 EQUIPMENT

We have Tier 4 Equipment including Air Compressors & Generators for Sale & Rent! Your job may now require Tier-4. www.absoluteequip.com or Call 412-931-6655.


Safway Services
Safeguard Assets. Ensure Productivity. HAKI®

Protect assets and equipment. Keep facilities open and operational. Maintain schedules regardless of weather. Ensure smooth and continuous production. Easy to erect. Safway is the primary distributor of HAKI® products including HAKISPAN and HAKITEC® 750 – in North America.

 

Technology Publishing Co., 1501 Reedsdale Street, Suite 2008, Pittsburgh, PA 15233

TEL 1-412-431-8300  • FAX  1-412-431-5428  •  EMAIL webmaster@paintsquare.com


The Technology Publishing Network

Durability + Design PaintSquare the Journal of Protective Coatings & Linings Paint BidTracker

 
EXPLORE:      JPCL   |   PaintSquare News   |   Interact   |   Buying Guides   |   Webinars   |   Resources   |   Classifieds
REGISTER AND SUBSCRIBE:      Free PaintSquare Registration   |   Subscribe to JPCL   |   Subscribe to PaintSquare News
MORE:      About PaintSquare.com   |   Privacy policy   |   Terms & conditions   |   Site Map   |   Search   |   Contact Us