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Director Regulatory Affairs CMC

Director Regulatory Affairs CMC

Job Title: Director Regulatory Affairs CMC
Contract Type: Permanent
Location: Seattle, Washington
Industry:
Salary: Negotiable
Start Date: asap
Reference: HQ00052417
Contact Name: Pavlina Bullaj
Contact Email: p.bullaj@sciproglobal.com
Job Published: February 07, 2017 16:27

Job Description

Director Regulatory Affairs CMC

Industry: Pharmaceuticals/ Biotech

Location: Seattle

One of my key clients is currently looking for a Director Regulatory Affairs CMC based in their head office in Seattle.

As the Director of Regulatory Affairs CMC, you will be responsible for helping to put together the CMC strategy for international submissions in accordance with the current regulations & department procedures. This will also include the ability to then implement the strategy to successful product registration. As an ideal candidate you will need to have a comprehensive understanding of CMC regulatory requirements including FDA& ICH guidelines and relevant government regulations as they apply to registration.

Experience

  • Setting the standard for CMC regulatory submissions & driving content for CMC documentations to regulatory agencies (IND/NDA/CTA/BLA/MAA)
  • Managing regulatory CMC activities within time and budgets for approved project plans
  • Coordinating the preparation of CMC submissions through editing and approval of final draft documents including review for quality
  • Coordinating preparation of information and related activities for CMC meetings with health authorities
  • Interacting with domestic and foreign regulatory agencies on CMC issues
  • Serving as the regulatory representative at project meetings and interacts with personnel from corporate partners in order to achieve common goals
  • Negotiating, interacting with, and supervising the activities of contract manufacturing organizations (CMO's) in the preparation of regulatory submissions

Education

  • BS/MS degree in Chemistry or other scientific discipline
  • 10 + Years in Regulatory Affairs - 5Years within CMC
  • Experience in preparing/reviewing regulatory IND/CTA and CTD NDA paper and/or electronic submissions