Abbott Sr. Regulatory Affairs Specialist in Irving, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
With limited supervision, coordinates and compiles regulatory documentation for submission to health authorities and contributes to Regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness.
Track publishing related registration activities.
Communicate with business partners to track, complete, and distribute submissions.
Analyzes reports and metrics from tracking tools; identifies trends and ramifications.
Lead junior operations team members, developing their skills/abilities, verifying work and assisting them in being more efficient in the publishing role.
Support RA Submission Leads in ensuring on time submission deliverables by tracking them and developing mitigation plans to risks and issues that are identified.
Support ongoing RA Operation system implementations and process improvements.
Compile high quality submissions in compliance with technical requirements from regulatory authorities.
Project team participation to identify appropriate planning, formats, deliverables, and timelines associated with investigational and marketed product submissions across all therapeutic areas.
Coordinate submission publishing activities among internal Regulatory functions and external publishing technical resources (third party publishing resources and agency submission gateway owners).
Provide support as necessary to assure high quality published output and to meet established deadlines.
Input submission tracking information into registration tracking system.
Represent RA Operations on Regulatory sub teams and mitigate/escalate issues.
Act as submission representative on cross-functional teams such as process improvement teams.
Facilitate process discussions and implement processes and standards relating to publishing and submission management.
Responsible for the evaluation, implementation, testing, validation of software updates or enhancements to RA operations systems. Facilitate and participate in project team meetings to keep projects progressing.
Function as a team lead when publishing Manager is not available prioritizing work and facilitating issue resolution or escalation.
Propose and implement strategic business approaches that address ever changing regulatory requirements while not disrupting business continuity.
Lead, plan and execute projects that support the strategic direction of EPD, working independently or as part of a team.
Contribute to development of business related training materials. Train team members and business partners on departmental/organizational practices.
Contribute to organizational change management across the organization as systems and tools are deployed.
2-5 years business related experience
3-6 years minimum pharmaceutical publishing experience. Expertise with EDMS (Documentum based), publishing and or registration management systems , Adobe Acrobat or demonstrated experience with similar tools
Demonstrated ability to quickly learn new technology
Expertise with electronic submission formats like eCTD, ACTD and NeeS. Knowledge of regulations
Excellent written and oral communication skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org