Regulatory Operations Specialist

Location: Gaithersburg, MD
Date Posted: 06-11-2018
In this role, the candidate will be responsible for end-to-end document and submission publishing, which includes planning, compiling, publishing, delivering and archiving of regulatory submissions in accordance with health authority standards and  procedures. The candidate will provide support to project teams, external partners and stakeholders on topics related to document and submission publishing in accordance to Global Regulatory Operations Operating Model. 

Essential Requirements 

• University degree or equivalent experience in life sciences or technical field 
• Minimum 2 years hands-on experience with publishing eCTD submissions 
• Demonstrated ability to work in accordance with processes 
• Demonstrated ability to work collaboratively in a global team environment and to have good project management skills 
• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment 
• Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications 
• Excellent English written and verbal communication skills. 

Desirable Requirements 

• Experience of system administration for validated applications within a regulated environment 
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions 
• Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox) 
•  submission compilation, publishing, approval processes, tools and standards 
• Ability to thrive in a rapid paced environment 
• Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business 
• Good problem and conflict resolution skills.
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