MANAGER/SR. MANAGER – REGULATORY OPERATIONS

PRIMARY OBJECTIVE OF POSITION:
The position will be responsible for providing regulatory document and submission publishing and management expertise for Elan's R&D and operational supervision for Regulatory Operations.

RESPONSIBILITIES:
Perform and supervise all activities associated with the publishing and management of regulatory documents and submissions using EMC Documentum, ISI eCTDXpress, Liquent CoreDossier, ISI Toolbox, Adobe Acrobat and MS Word.  This includes submission publishing, printing, binding, labeling, distributing, shipping, tracking, checking submission quality, bookmarking and hyper-linking submission documents, reference ordering, CD/DVD burning, submission notification, template creation and management, submission document formatting, separating / merging documents, VDOC creation, and checking document quality. 
- Drive business process improvements. 
- Manage projects and participate in project teams for the publishing of regulatory documents and submissions, delegation of tasks, which include coordinating all aspects of publishing activities for an assigned project, track publishing timelines, oversee, delegate and prioritize project-related tasks of the Regulatory Operations staff assigned to a project, develop project-related work instructions, and work closely with project team members including in house and/or third-party authors. 
- Responsible for providing supervision and assistance in the day-to-day activities of the Regulatory Operations department and its personnel, or as assigned by the Director when required, including hiring new personnel and managing performance. 
- Maintaining a working knowledge of regulatory submission guidelines (US and EU). 
- Provide training. 
- Regulatory records management. 
- Managing departmental tracking sheets. 
- File drive and website content management. 
- Coordination of manuals, work instructions and guideline updates. 

EXPERIENCE:
Minimum of 4-6 years publishing regulatory documents and submissions, particularly electronic submissions, using appropriate software tools in a biotechnology, pharmaceutical and/or CRO environment.
- Minimum of 2-4 years of publishing project management/lead experience.
- Minimum of 2 years managerial/supervisory experience in regulatory.
- Proficient in MS Word, MS Excel, MS Access and Adobe Acrobat

SPECIAL TRAINING:
- Document and eCTD submission publishing and management tools training, specifically on EMC Documentum, MS SharePoint, ISI eCTDXpress, Liquent CoreDossier, ISI Toolbox, Adobe Acrobat and MS Word.
- Document formatting, word processing and typing training, specifically on MS Word, MS Excel, MS Access and Adobe Acrobat.

SKILLS AND ABILITIES:
- Working knowledge and expertise with US and EU electronic submission (eCTD) requirements and guidelines.
- Strong computer skills.
- Strong attention to detail.
- Strong problem solving skills.
- Highly organized.
- Ability to deal effectively with and satisfy customers.
- Ability to work effectively in project teams.
- Ability to work under pressure and deal with changing priorities.
- Ability to conduct live presentations.
- Ability to effectively communicate issues to manager and resolve issues with subordinates.
- Ability to proactively report project status and issues to manager and project team.
- Must be proactive and self directed.
- Detailed knowledge of project management and scheduling techniques.
- Ability to train others.

Travel: up to 10%