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Senior Regulatory Specialist

Lake Zurich, IL 60047

Posted: 04/03/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2326

Our client currently has 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.

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/NDAs, 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 FK with regulatory agencies and industry groups as applicable
    • Uses persuasive communication to influence regulatory agencies
  • Train new regulatory scientists on RA and FK 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:
  • 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.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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