Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
Post: Sr. Spl Regulatory Affairs
JOB DISCRIPTION:
THE POSITION:
The Sr. Specialist Regulatory Affairs will be responsible to work closely with the IT organization to ensure that the business needs of the Regulatory Affairs organization are being adequately addressed by IT system and business process improvement initiatives.
CORE JOB RESPONSIBILITIES:
- Managing the day to day project management of specific initiative.
- Partnering with IT Project Manager (PM) to ensure successful implementation or adoption of business process change, technical solution development, end user support model and strategic outlook for regulatory systems (Registration Management, Submission Management or Document Management).
- Collecting information from a broad range of business users to map and analyze current and future business processes, reaching consensus across business users on prioritized lists of user requirements for any system implementation.
POSITION ACCOUNTABILITY / SCOPE:
- Collaboration within EPD Regulatory and other EPD functional areas to successfully deliver high quality deliverables and deploy best practice solutions.
- Partners with EPD IT to ensure maintenance of key systems and business processes.
- Communicate initiative progress by producing project reports to provide timely and accurate project status and decision support information to appropriate forums. Makes recommendations based on current project status to resolve issues.
- Escalation as appropriate successes and issues to Manager.
MINIMUM EXPERIENCE / REQUIREMENT:
- Minimum of 5 years’ experience in the healthcare industry is required, with at least 1 year in Regulatory Affairs, preferably for pharmaceutical products.
- Must have project management experience and experience with the successful implementation of highly complex business and technology initiatives.
- Knowledge of global regulatory requirements and application to electronic document management, registration management, regulatory submission publishing systems and SharePoint is highly desirable.
- Advanced knowledge and experience with Microsoft office products (Word, Excel and Power Point) required.
EDUCATION:
Preferred Education: Bachelor’s degree; preferably with a business and/or analytical focus. Advanced degree is preferred.
Project Management Institute (PMI) Project Management Professional (PMP) certification is preferred.
See All B.Pharm Alerts B.Sc Alerts D.Pharm Alerts
See All Other Jobs in our Database
.png)
