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Job Details

Associate Director, Regulatory Affairs CMC

Company: RBW Consulting
Location: Basking Ridge, NJ (July 2017)
Reference: RA-ADRACMC-ENJ
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

For more information on the above role, please do not hesitate to get in touch today with RBW Consulting today. You can find us directly on +1 (646) 586 9087, or contact the consultant directly on ross.apted@rbwconsulting.com for a confidential chat.

Requirements:

Associate Director, Regulatory Affairs CMC

Edison NJ (Moving to a new site in New Jersey – July 2017)

Job Summary:

This position serves as a RA CMC Project Representative to the CMC sub team and the RA team, whilst also serving as an ad hoc member to other Integrated Projects that are at late stage.

This post in particular will be assigned developmental and post marketing projects with supervision, including those that are third party.

The role will develop strategy, prepare content templates and lead technical teams in preparation of various submission documents, including but not limited to the following:

  • IND
  • IB
  • NDA
  • Amendments
  • Supplements

This position will author said regulatory documents where necessary with supervision.

The role will also include aspects of the following:

  • Regulatory Risk Assessment
  • FDA Company Liaison where needed
  • Support Heath Authority Meetings (preIND, EOP2, pre-NDA, Type C)
  • Develop a global awareness of global submissions, and act as the RA CMC representative (PhRMA, USP, ICH, due diligence, RA Inspections)

Role Responsibilities:

  • Planning for Development and Post Marketing Projects
  • Execution and follow-through of Strategy and Submissions
  • FDA Interactions
  • Regulatory Knowledge – expert knowledge of US regulatory guidances, and serving as a RA CMC Representative supporting company initiatives

Role Qualifications:

  • M.S. in a scientific discipline with8-10 years pharmaceutical industry experience with 4+ years DIRECT CMC regulatory experience

OR

  • PhD. In a scientific discipline with 6-8 years pharmaceutical industry experience and 4+ years DIRECT CMC regulatory experience

For more information on the above role, please do not hesitate to get in touch today with RBW Consulting today. You can find us directly on +1 (646) 586 9087, or contact the consultant directly on ross.apted@rbwconsulting.com for a confidential chat. 

Apply for this job: Associate Director, Regulatory Affairs CMC

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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