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Regulatory Affairs Associate I

Round Lake, IL 60073

Posted: 06/18/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 608580 Is job remote?: Yes Country: United States

Job Description

Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global products.

Essential Duties and Responsibilities:
• Supports regulatory project plan execution
• Maintain awareness of regulatory requirements and ensure continued learning
• Maintain regulatory files in a format consistent with requirements
• Participate as an active team member of project teams as required
• Compile and prepare responses to questions from regulatory authorities according to plan
• Edit and proofread regulatory documentation
• Assist in preparation and review of labeling, SOP’s, and other departmental documents
• Compile under supervision regulatory documents for submission
• Track status and progress of regulatory documentation
• Understand Regulatory Affairs' position in small project teams

Qualifications:
• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Proofreading and editing skills

Education and/or Experience:
• Bachelor’s degree or country equivalent in a relevant scientific discipline
• Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification
• Regulatory experience (not mandatory) preferably within a healthcare environment

Pay ranges between $30-40/hr based on experience 

 

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 and The Planet Group of Companies are equal opportunity employers. 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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About Round Lake, IL

Ready to kickstart your career in the vibrant Round Lake, Illinois area? Our job listings are brimming with enticing opportunities waiting to be explored! Nestled in Lake County, Illinois, Round Lake boasts a perfect blend of small-town charm and big-city amenities. With proximity to iconic landmarks like the Chain O'Lakes State Park and the renowned Genesee Theatre, there's no shortage of recreational activities and cultural experiences here. Indulge in the local cuisine at Round Lake's charming eateries, catch a show at the state-of-the-art Round Lake Area Park District's Cultural & Civic Center, or cheer for the Chicago Bears at the nearby Soldier Field. Discover why Round Lake, IL is not just a place to work, but a place to thrive and find fulfillment in your career journey.

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.