One of our clients in north Los Angeles is looking for a Regulatory Ops Specialist (II or III) with the following skills and experience:
Description of Role/Responsibilities:
Client is looking for a Level II or Level III Regulatory Ops Specialist. Looking for someone with AMPLE experience not a junior person. Selected candidate will need to hit the ground running from day one
Top 4 Skills:
Formatting word documents using eCTD
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.
Writing up SOPs (Standard Operating Procedures)
Creating Process around development operations work
Building global regulatory submissions (eCTD or Non-eCTD)
Experience with publishing eCTD submissions
Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox)
Knowledge of 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
Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications
Excellent English written and verbal communication skills.
*What is an eCTD?- The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). It is basically an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.
Interested candidates may submit their resumes online or call at for further information regarding the position.
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Beacon Hill. Employing the Future
Regulatory Ops Specialist (II or III)
Beacon Hill Staffing Group, LLC