Regulatory Affairs Consultant I Job at Planet Pharma, Chicago, IL

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  • Planet Pharma
  • Chicago, IL

Job Description

Join to apply for the Regulatory Affairs Consultant I role at Planet Pharma 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Consultant I role at Planet Pharma Get AI-powered advice on this job and more exclusive features. Job Description Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products. Job Description Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products. Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality. Responsible for electronic submissions and documents meeting regulatory agency and the companies submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines. Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. Competent in the use of electronic document management and submissions publishing tools. 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe. Experience overseeing publishing vendors preferred. Pay ranges between $58-65.50/hr based on expereince The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Legal Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Regulatory Affairs Consultant” roles. Chicago, IL $69,900.00-$117,000.00 2 weeks ago Chicago, IL $80,325.00-$112,455.00 1 week ago Morton Grove, IL $160,000.00-$180,000.00 2 weeks ago Sr. Analyst, Labeling Regulation, Regulatory Affairs Glenview, IL $88,000.00-$110,000.00 1 week ago Sr Manager Regulatory and Scientific Affairs (Remote) Des Plaines, IL $165,000.00-$190,000.00 1 week ago Scientific & Regulatory Affairs- Sr. Specialist Chicago, IL $107,071.00-$147,223.00 2 weeks ago Sr. Manager, Regulatory Affairs Corporate Chicago, IL $112,425.00-$157,395.00 5 hours ago Senior Manager Regulatory Affairs, CMC and Regulatory Sciences Chicago, IL $120,000.00-$155,000.00 1 week ago Northbrook, IL $101,000.00-$135,000.00 3 weeks ago Senior Director of Regulatory Operations, 2 Hour Learning (Remote) - $400,000/year USD Chicago, IL $74,200.00-$126,200.00 2 weeks ago Chicago, IL $120,000.00-$150,000.00 2 weeks ago Scientific Director, Medical Affairs - Oncology Mettawa, IL $177,000.00-$336,000.00 15 hours ago Specialist - Scientific & Regulatory Affairs Chicago, IL $85,875.00-$118,083.00 1 week ago Regulatory Affairs Specialist-Cosmetic Raw Materials Crystal Lake, IL $75,000.00-$95,000.00 4 weeks ago Regulatory Affairs Specialist- Cosmetic/Drugs Northfield, IL $79,560.00-$115,440.00 1 week ago 2026 Regulatory Compliance Consultant Intern Compliance Associate, Financial Regulatory Affairs Chicago, IL $74,200.00-$126,200.00 2 weeks ago Compliance Associate, Financial Regulatory Affairs Chicago, IL $74,200.00-$126,200.00 1 week ago Sr. Consultant, Regulatory Reporting & Compliance, Omnium Services Chicago, IL $83,100.00-$141,300.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Planet Pharma

Job Tags

Full time, Local area, Remote work,

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