Regulatory Affairs Manager (temp / contract)

Location: Charlotte, NC
Job Type: Contract
Hourly: $25.00 - $35.00
Degree: Bachelor;
Date: 5/15/2017
Job ID: 02483005
Job Description

Key Responsibilities:

  • Coordinate, assemble and/or prepare for submission various materials to the FDA such as ANDAs/supplements, periodic reports for approved products.  
  • Assist VP to lead all interactions with regulatory agencies.
  • Point of contact to local regulatory authorities and maintain the communication system.
  • Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams.
  • To have overall responsibility for ensuring that all state regulatory requirements are addressed.
  • Responsible for provincial submissions in coordination with marketing.
  • Change control evaluation and follow up.  
  • Identify need for new regulatory policies and implement new regulatory strategies, processes and SOPs, where applicable.
  • Provide current status of regulatory guidances, familiar with latest regulations, awareness of competitive performance.
  • Providing support to VP, RA to form networks with company senior management, updating them regularly on regulatory developments.
  • Ensure that the interfaces between Regulatory and other departments are managed optimally.

Education:

  • Bachelor's degree in Regulatory Affairs or related field required.
  • M.S. in Regulatory Affairs, or PharmD, preferred.
  • 4-5 years of Regulatory Affairs experience in the pharmaceutical industry.
Skills:
  • Demonstrates a thorough knowledge and understanding of all US FDA  regulations, guidelines
  • Balances a sense of urgency of time pressures with adherence to all regulatory requirements 
  • Demonstrates advanced oral and written communication skills including editing of documents prepared by others