Job Description

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.

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