Job Description
Hybrid schedule - Lake County - (Onsite Tuesday, Wednesday, Thursday)
1 year to start
Manager's Update
Looking for project management
Working with a lot of teams
Working with a regulatory agency
Project management of process improvement
Experience with the regulatory system and Change management
PMP is preferred but not required
Pharma or medical device experience will be fine
Veeva, Salesforce is great to have
Strong Communication skills
Industry experience
Microsoft Office experience
Regulatory experience can be considered
International experience can be considered (Europe, China, or India )
Project management and regulatory experience
Regulatory experience or Project management
A candidate having only regulatory affairs experience will work
More years of experience will also work
Preferred Education:
Batchelor’s degree
RAC Certification from the Regulatory Affairs Professionals Society (RAPS)
NOTE:
Higher education and/or RAC certification may compensate for years of experience.
Years of experience may also compensate for lower education.
Major responsibilities:
Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s). May assist Enhancement Leads to triage and disposition enhancement requests.
Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
Support relevant complex and/or cross-functional initiatives as needed.
May lead or co-lead straightforward, departmental process improvement activities.
May be responsible for generating regulatory planning metrics, reports, and/or other system-related needs.
Assist in system-related training and/or updates to training material / logistics.
Required Experience:
2 years of pharmaceutical or industry-related experience
Experience working in a complex and matrix environment
Strong oral and written communication skills
Experience / understanding / use of software tools
Keen awareness of cultural nuances / Proven ability to work in a global environment
Strong attention to detail and problem-solving skills
Preferred Experience:
Experience in Regulatory Affairs and/or Project Management preferred but may consider related area
Understanding of global regulations
MS Project experience preferred
Additional Information
All your information will be kept confidential according to EEO guidelines.