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Senior Regulatory Specialist

Lake Zurich, Illinois

Post Date: 10/30/2017 Job ID: 1723 Job Category: Clinical: Regulatory

We currently have an opportunity for a Sr. Regulatory Specialist who will be responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers.  Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics.  Trains new regulatory specialists.  You will report to a Manager of Regulatory Affairs.  This position has no direct reports.

Job Responsibilities:
  • Representing RA on project teams and providing regulatory guidance
    • Serves as a role model for effectively communicating with individuals in different functions and at different levels
    • Shares expert knowledge of complex issues
  • Reviewing technical documents for cGMP and regulatory compliance
    • Shares expert knowledge of complex technical concepts
    • Trains and coaches others in regulatory requirements
  • Preparing and filing high-quality submissions to regulatory authorities (A/NDA’ s, Supplements, Amendments, Annual Reports and DMF Updates)
  • Communicates importance of quality assurance
  • Develops quality standards for RA
  • Provide regulatory decisions with regard to acceptability of submission documents and decisions
  • Develops and brainstorms regulatory strategy and options for resolving complex and difficult issues that could result in project termination if not addressed
  • Filing all applications in accordance with predetermined timelines
    • Shares with others best practices for planning, organization and time management
  • Representing the company with regulatory agencies and industry groups as applicable
    • Uses persuasive communication to influence regulatory agencies
  • Train new regulatory scientists on RA and company systems
  • Mentor regulatory scientists regarding the regulations
    • Provides comments and perspective on proposed regulations
  • Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
    • Draws out underlying team conflicts and facilitates agreement among team members
    • Actively seeks ways to improve team processes and areas for improvement
    • Dedicates time and energy to remove obstacles to facilitate achievement of team goals
  • Ensuring that supervisor is aware of activities and progress
  • Projecting professionalism and a courteous, cheerful and cooperative demeanor
    • Maintain ongoing relationships with multiple customers as a trusted advisor
  • Other duties as assigned

Qualifications/ Requirements:
  • At minimum, a Bachelor Degree in a scientific discipline and a minimum of 4 years’ experience in pharmaceutical Regulatory Affairs.
  • Experience in preparing and filing complete A/NDA' s, Supplements, Amendments and Annual Reports to FDA.
  • Thorough understanding of the CFR, FDA/ICH guidelines and cGMP' s as they pertain to pharmaceuticals.
  • Well-developed communication skills.  

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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