Senior Specialist Regulatory Affairs

Company: Abbott Laboratories
Location: Santa Clara
Posted on: May 15, 2022

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.MAIN PURPOSE OF ROLEWith 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. -MAIN RESPONSIBILITIES

• 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 Division, 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.QUALIFICATIONS---------------EducationBachelors Degree ( - 16 years) on a related field or an an equivalent combination of education and work experience.Experience/Background
  • 3-6 years regulatory affairs submissions experience.
  • 3-6 years pharmaceutical publishing experience preferred.
  • 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.

Keywords: Abbott Laboratories, Santa Clara , Senior Specialist Regulatory Affairs, Other , Santa Clara, California