Sr. Regulatory Publishing Specialist
Mallinckrodt Pharmaceuticals | |
United States, Missouri, St. Louis | |
Nov 25, 2024 | |
Job Description SUMMARY OF POSITION: The Senior Regulatory Publishing Specialist will be part of the Regulatory Operations team within the Regulatory Affairs function for Specialty Generics of Mallinckrodt Pharmaceuticals and will coordinate the publishing process to ensure timely and accurate submissions to the FDA and other agencies. This position will assemble and publish US FDA eCTD submissions and other submission types for global applications. ESSENTIAL FUNCTIONS:
MINIMUM REQUIREMENTS: Education: Bachelor's degree in scientific discipline Experience: Five to seven years of related experience. A minimum of four years of experience in eCTD Publishing & Electronic Processing is required. Experience with electronic submission software (InSight Publisher) and/or Veeva. Knowledge of ICH and FDA guidance required. Knowledge of Health Canada and EU regulations preferred. Skills/Competencies: Ability to set and manage multiple priorities and projects to complete tasks within established timelines. Excellent interpersonal, oral, and written communication skills. Able to work with multiple groups of people at one time. Proficient with computers and Microsoft Office. Other Skills: Strong interpersonal skills, including ability to remain calm, professional, diplomatic, and positive. Flexibility to accept new duties and responsibilities as assigned. Ability to work in a fast paced environment. Ability to allocate down-time effectively. ORGANIZATIONAL RELATIONSHIPS/SCOPE: This position reports to the Senior Director, Regulatory Affairs and has no direct reports. WORKING CONDITIONS: Typical office working conditions. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. |