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Regulatory Affairs Manager II

Oakbrook, IL 60614

Posted: 04/18/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 618783 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $58-63/hr

Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.
Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.

Submissions support:
Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions.

Oversee outsourced publishing deliverables 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. 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.
Competent in the use of electronic document management and submissions publishing tools.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.