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
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