Description
Regulatory Operations / Publishing Role:We have had several new Regulatory Publishing / Operations roles come through at various levels.
If you are interested to hear more information on any of these roles please call our Senior Regulatory consultant Natalie Hopkins on or email her directly to n.hopkins(a)realstaffing.com
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Role 1: Regulatory Operations Specialist
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Locations: Berkshire (option for 2 days a week home working if needed)
Salary: TBC
This is with a Global Company offering excellent career progression and development.
- You will need at least 1 year experience in Regulatory Publishing / Operations in the Pharmaceutical industry
- Be keen to join a dynamic working environment
- Performs publishing and quality control tasks on submission components
- Manages and is responsible for project content
- With guidance, oversee workflow progress
- Proficiency with Adobe Acrobat and ViewPoint
- Responsible for overall quality of project deliverables
- Responsible for submission compilation and/or project completion with assistance
- Under the direction of Submission Manager or Manager, monitor individual and team time charged to project(s)
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Role 2: Regulatory Operations Manager
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Locations: Berkshire, with the option for some home working if needed.
Salary: Competitive + Car allowance and benefit package
- Significant experience in the pharmaceutical industry, at least 5- 10 years +
- Practical Regulatory Operations experience with electronic submissions, preferably eCTD
- Knowledge and experience with leadership and people management
- Project management skills
- Knowledge of the European Regulatory and EU/ICH Guidelines
- Supervisory skills
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Role 3: Regulatory Operations Manager
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Locations: Hertfordshire, with the option for some home working if needed.
Salary: £55,000 - £65,000 + Car allowance and benefit package
- Manage the daily activities and workload of site publishing team ensuring that individuals are trained and comply with all SOPs and internal publishing standards.
- Publish high-quality, technically acceptable eCTD submissions for Health Authority filings.
- Coordinate and lead major and complex routine/lifecycle management eCTD submission projects.
- Act as system Subject Matter Expert/initial point of troubleshooting for in publishing tools and standards.
- Prepare and deliver performance management and career development plans for staff.
- Participate in Global Regulatory Operations and Global Regulatory Affairs team meetings.
If you are interested to hear more information on any of these roles please call our Senior Regulatory consultant Natalie Hopkins on or email her directly to n.hopkins(a)realstaffing.com.