Job Title

• Dossier Manager
  

Position Description

• The Dossier Manager will be an integral member of the Global Regulatory Dossier Management Group. 
• On a daily basis, the Dossier Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, overseeing publication activities, and utilizing a wide array of document management, authoring, and publishing tools. 
• The Dossier Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.
  

Position Responsibilities

• Working closely with the Regulatory Leads, the Dossier Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management. 
• Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines. 
• Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management. 
• Identify issues that may delay product or project and recommend appropriate action. 
• Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology. 
• Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity. 
• Prepare and maintain templates that meet Regulatory electronic submission standards. 
• Assist in establishing electronic submission capability at company, focusing on implementing the eCTD and representing Regulatory business function on technology teams. 
• Manage compliance-related submissions and activities.

Position Requirements

• Minimum of 4 years of experience within the pharmaceutical industry and strong project management and/or submission management experience is required. 
• Skill in using desktop applications and proficiency in computer systems and procedures is required. 
• Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired
• 4 years Regulatory Affairs or pharmaceutical experience is required
• Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance