Full time Senior Regulatory Affairs Associate openings in the Waukegan, IL area with a major pharmaceutical company! Starting ASAP! Apply now with Luke H. at A-Line!
Position Summary: Regulatory Affairs Submission Management manages simple to moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams and their supervisor the Senior Associate establishes and maintains submission planners and associated timelines facilitates tactical submission team meetings and represents Submission Operations on Global Regulatory Project Teams for assigned products.
Pay: $28-$35 hourly
Schedule: 40 hours weekly working 8am-5pm, with minimal to no overtime. Remote during COVID.
With manager support manages/provides operational oversight to ensure timely high quality regulatory submissions.
Participate in the development of project plans using established templates.
Plans and negotiates publishing timelines with the teams.
Effectively manages multiple projects and competing priorities.
Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
Plans and conducts submission team meetings.
Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
Identify obstacles and work with manager/mentor to develop solutions for the team.
Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
Demonstrates submission team leadership skills and ability to influence without direct authority.
Builds and maintains positive relationships internally and externally.
Some supervision of projects and assistance with priority setting required.
Receives project assignments from manager but has responsibility for managing own projects.
Reviews project progress with manager on a regular basis with direction provided on follow-up.
Identifies opportunities for process improvements.
May participate on internal project teams to update business processes.
Bachelor’ s degree. Note: Years of experience may also compensate for lower education.
4 years pharmaceutical or industry related experience.
Experience working in a complex and matrix environment.
Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat.
PMP and RAC certificates a plus but not required.
Experience in Regulatory Affairs preferred but may consider QA RD/support Scientific affairs operations or related area.
Experience in Regulatory Operations including regulatory submission project management and/or submission publishing is preferred.
Full benefits available after 90 days: Medical, Dental, Vision, Life, Short-term Disability
401k after 1 year of employment: With Employer Match and Profit Sharing
GREAT Hours! Monday through Friday, 40 hours per week with Overtime Potential
Competitive Pay Rate!
Keywords: Regulatory Affairs, Regulatory Compliance, Project Management, PMP, RAC, Research & Development, R, Quality Assurance, Clinical, Pharmaceutical, Regulatory Operations, Quality Control, Medical Writing, Clinical Regulatory Documents, Regulatory Submission Project Management, Trial Master File, TMF, ICH, Regulatory Submission Publishing, GCP Guidelines.
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