Regulatory Affairs Associate at Teklysium Inc

Chicago, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Jul, 26

Salary

0.0

Posted On

21 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project management, Regulatory affairs, Process improvement, Change management, Veeva, Salesforce, Communication skills, Microsoft Office, Data analysis, Regulatory planning, Cross-functional collaboration, Global environment experience, Problem-solving, Attention to detail, MS Project

Industry

IT Services and IT Consulting

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.

Responsibilities

The associate will execute regulatory planning assignments and serve as a key member of the Regulatory Portfolio Management team to enhance reporting systems. They will also partner with strategic planning colleagues to manage datasets and lead departmental process improvement initiatives.